BRPI1015278A2 - tissue removal device with high reciprocity rate - Google Patents

Abstract

FABRIC REMOVAL DEVICE WITH HIGH RECIPROCITY RATE. A removal device is described tissue. The device includes an external tubular body, a tubular body inner and a cutting edge on the inner tubular body. The tubular body external window includes a window, which can be opened or closed by removing the cutting edge. The cutting edge has a hardness that exceeds the hardness of the inner tube material. The cutting edge may have a Rockwell C hardness at least about 50, while the inner tube has a hardness Rockwell C no more than about 40. The cutting edge can be formed by a grinding step, and the inner tube can be formed by a grinding step to pull. The fabric cut by the cutting edge can be removed at a rate of at least about 1.8 grams per minute through the tube internal, and the external tubular body can have an external diameter of no max. about 3.5 mm.

Description

“Patent descriptive report for:“ TISSUE REMOVAL DEVICE WITH HIGH RECIPROCITY RATE ”.

REMISSIVE REFERENCE TO RELATED APPLICATIONS This application is a continuation in part of US patent application Serial No. 12 / 098.250, filed on April 4, 2008 (entitled "METHOD, SYSTEM AND DEVICE FOR TISSUE REMOVAL”), claiming the benefit under 35 USC S $ 119 (e) of North American Provisional Application Serial No. 60 / 910,618, filed on April 6, 2007, North American Provisional Patent Application Serial No. 60 / 910,625, filed on April 6, 2007, and US Provisional Patent Application Serial No. 60 / 986,912, filed on November 9, 2007, all of which are hereby incorporated by reference. This application is partly a continuation of US Patent Application Serial No. 12 / 098,318, filed on April 4, 2008 (entitled “SYSTEM FOR USE IN PERFORMING A

MEDICAL PROCEDURE AND INTRODUCER DEVICE SUITABLE FOR USE IN SAID SYSTEM "), which claims the benefit under 35 USC S $ 119 (e) of North American Provisional Order Serial No. 60 / 910,618, filed on April 6, 2007, and the US Provisional Patent Application Serial No.

60 / 910,625, filed on April 6, 2007, all of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION The present invention generally relates to methods, systems and devices for removing tissue and more particularly relates to methods, systems and devices well suited for the removal of uterine fibroids and other abnormal gynecological tissues.

Uterine fibroid is believed to 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 cases, uterine fibroids can grow to be several inches in diameter and can cause symptoms such as - menorrhagia (prolonged bleeding or heavy menstruation), pelvic pressure or pain and reproductive dysfunction.

Current treatments for uterine fibroids include pharmacological therapy, hysterectomy, embolization of the uterine arteries and hysteroscopic resection. Pharmacological therapy typically involves the administration of NSAIDs (non-steroidal anti-inflammatory drugs), combinations of estrogen and progesterone and GnRH (gonadotropin releasing hormone) analogs. However, current pharmacological therapies are very ineffective and merely palliative.

In comparison, a hysterectomy involves surgical removal of a patient's uterus.

For this reason, hysterectomy represents a highly effective way to rid 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 its widespread use, hysterectomies also have some disadvantages, such as loss of fertility, sexual dysfunction and the risks commonly associated with a major surgical procedure, such as bleeding, injuries, infections, pain and prolonged recovery.

Embolization of the uterine arteries 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 source and eventually causing it to shrink and die.

Although this procedure is less invasive than a hysterectomy, it often results in pain-related post-surgical complications.

In addition, doctors who are trained to perform uterine artery embolization are typically interventional radiologists, as opposed to doctors trained specifically to care for gynecological problems, while doctors trained specifically to care for gynecological problems typically do not have the ability to perform catheter-based uterine artery embolization.

Hysteroscopic resection typically involves inserting a hysteroscope (ie, a viewing scope) into the uterus through the vagina, that is, transcervically, and then cutting the fibroid from the uterus using a device distributed to the fibroid by the hysteroscope.

Hysteroscopic resections typically fall into one of two varieties.

In a variety, an electrocautery device in the form of a loop-shaped cutting wire is fixedly mounted at 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 energy unit for the device through a conductive block applied to the patient's skin.

In this way, the tissue is removed by the contact of the loop with the part of the wall of the uterus of interest. Examples of such devices are disclosed, for example, in U.S. Patent No. 5,906,615, inventor Thompson, issued on May 25,

1999.

5 In the other variety of hysteroscopic resection, an electromechanical cutter is inserted through a working channel in the hysteroscope. Tissue is then removed by contact with the cutter, which normally has a rotating cutting instrument, with the part of the uterus wall of interest. Examples of the variety of the hysteroscopic resection electromechanical cutter are disclosed, for example, in U.S. Patent No. 7,226,459, inventors Cesarini et al., Issued on June 5, 2007; American Patent No. 6,032,673, inventors Savage et al., Issued March 7, 2000; American Patent No. 5,730,752, inventors Alden et al., Issued March 24,. 1998; American Patent Application Publication No. US2006 / 0047185 Al, inventors Shener et al., Published on March 2, 2006; and PCT International Publication No.

99/11184, published on March 11, 1999, all of which are incorporated herein by reference.

In both of the above-described varieties of hysteroscopic resection, prior to the removal of the fibroid, the uterus is typically stretched to create a working space within the uterus. (Such a workspace typically does not exist naturally in the uterus because the uterus is a flabby organ. As such, the walls of the uterus are usually in contact with each other, when in a relaxed state.)

5. The conventional technique for creating such a working space inside the uterus is to administer fluid to the uterus through the hysteroscope under sufficient pressure to cause the uterus to be distended. Examples of the fluid conventionally used to stretch the uterus include gases such as carbon dioxide or, more commonly, liquids such as water or certain aqueous solutions (for example, saline or aqueous sugar-based solution). Where resection is performed using a resectoscope, it is typically necessary that the distension fluid is not a current conductor, so that electricity is not conducted to unwanted locations. However, since the distention fluid is administered under pressure (the pressure of which can be as large as 100 mm Hg or more), there is a risk, especially when the tissue is cut, that the distention fluid can be captured by a blood vessel in the uterus, that is, enter the vessel, to said uptake and can be quite harmful to the patient. Since excessive entry into the vessel can lead to death, it is common to monitor fluid absorption on a continuous basis using a scale system.

However, despite the aforementioned risks of entering the vessel, with adequate monitoring of fluid absorption, hysteroscopic resection is a highly effective and safe technique for the removal of uterine fibroids. However, a flaw with hysteroscopic resection is that it usually requires anesthesia to be administered to the patient. This is because conventional resectoscopes typically have a diameter greater than 7 mm and because conventional hysteroscopes, the type through which mechanical cutting devices are used. inserted, typically have a diameter of about 9 mm. On the other hand, the cervix cannot normally 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, has a high cost due to the environment and necessary support staff.

SUMMARY OF THE INVENTION The present invention provides a new method, system and device for removing tissue. The method, system and device, as described above, can be used, for example, to remove uterine fibroids and other abnormal gynecological tissues.

According to an aspect of the invention, a tissue removal device is provided, the tissue removal device comprising (a) a support; (b) an external tube, the external tube being fixed to the support and extending distally from there, the external tube including a resection window; (c) an inner tube disposed within the outer tube, the inner tube being slidable and rotatable with respect to the outer tube, the inner tube comprising a distal end; and (d) a drive mechanism to rotate the inner tube in relation to the outer tube and, at the same time, to swing the inner tube in translation in relation to the outer tube, so that the distal end of the inner tube rotates as it moves back and forth through the resection window, wherein said drive mechanism comprises a drive shaft shaped to include a double helical groove, said drive shaft being stationary in translation.

In accordance with an aspect of the present invention, a tissue removal device is provided. the device comprises an elongated external tubular body, which has a proximal end, a distal end and a lateral opening. An internal elongated tube is positioned inside the external tube, movable to open and close the side window. At least one cutting edge of the. fabric is provided in the inner tube, to cut the fabric that extends into the window. The cutting edge can be formed into a cutting tip, which is welded, joined, coated or otherwise connected to a distal end of the inner tube. The cutting edge has a hardness that exceeds the hardness of the inner tube material.

The tissue removal device can be configured so that the tissue cut by the cut edge is removed at a rate of at least about 1.8 grams per minute, and the outer tubular body has an outer diameter of no more than about 3.5 mm. The cutting edge can have a Rockwell C hardness of at least about 50, while the inner tube has a Rockwell C hardness of no more than about 40.

In one embodiment, the cutting edge is formed by a grinding step and the inner tube is formed by a drawing step. The device may further comprise a layer between the inner tube and the outer tube. The coating may be on the outer surface of the inner tube, and may comprise a titanium nitride alloy. The coating may comprise a Rockwell C hardness of at least about 50, in some embodiments at least about 60, and ideally at least about 70.

Additional aspects, features and advantages of the present invention will be set out, in part, in the description that follows. The modalities will be described in sufficient detail to allow persons skilled in the art to practice the invention, and it is to be understood that other modalities can be used and that structural or process changes can be made without departing from the scope of the invention. The following detailed description is therefore not to be considered in a limiting sense, and the scope of the present invention is best defined by the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS The associated drawings, which are hereby incorporated and constitute a part of this specification, illustrate various modalities of the invention and, together with the description, serve to explain the principles of the invention. In the drawings in which equal reference numbers represent equal parts: Fig. 1 is a partially exploded perspective view of a first embodiment of a tissue removal system constructed in accordance with the teachings of the present invention; Figs. 2 (a) to 2 (d) are various views of the tissue removal device shown in the figure. 1, the tissue removal device being shown in Figs. 2 (a) to 2 (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 in Fig. 1;

Figs. 4 (a) and 4 (b) are an exploded perspective view of the introducer device shown in Fig. 1;

Fig. 5 is a right perspective view of the introducer device shown in Fig. 1, with half

1j0 right of the support removed;

Fig. 6 is a longitudinal section view of the introducer device shown in Fig. 1;

Fig. 7 is an enlarged fragmentary perspective view shown in section, of the introducer device shown in

Fig. 1, with only the collector, protector and sheath being shown;

Fig. 8 is a view of the enlarged distal end of the multi-lumen sheath of the introducer device shown in Fig. 1;

Fig. 9 is an enlarged fragmentary view of the instrument guide assembly of the introducer device shown in Fig. 1;

Figs. 10 (a) and 10 (b) are fragmentary longitudinal section views of the alternate internal tubular members that can be used in the tissue removal device shown in Fig. 1; Fig. 11 is a side view of an alternative indicator sleeve that can be used in the tissue removal device shown in Fig. 1; Fig. 12 is a fragmentary side view, partly in section, of an alternative combination of a tissue removal device and an introducer that can be used in the tissue removal system shown in Fig.

1; Figs. 13 (a) and 13 (b) are fragmentary side views, partly in section, of an additional alternative combination of a tissue removal device and an introducer that can be used in the tissue removal system shown in Fig. 1; Fig. 14 is a fragmentary side view, partly in section, of an alternative tissue removal device that can be used in the tissue removal system of Fig. 1; Figs. 15 (a) and 15 (0) are seen in a fragmentary perspective and in a partially fragmented exploded perspective, respectively, of another alternative tissue removal device that can be used in the tissue removal system of Fig. 1;

Fig. 16 is a fragmentary side view of another alternative tissue removal device that can be used in the tissue removal system of Fig. 1; Fig. 17 is a fragmentary side view of an alternative tissue removal device that can be used in the tissue removal system of Fig. 1; Fig. 18 is a fragmentary perspective view of another alternative tissue removal device that can be used in the tissue removal system of Fig. 1; Fig. 19 is a fragmentary perspective view of another alternative tissue removal device that can be used in the tissue removal system of Fig. 1; Fig. 20 is a fragmentary perspective view of another alternative tissue removal device that can be used in the tissue removal system of Fig. 1; Fig. 21 is a fragmentary perspective view of another alternative tissue removal device that can be used in the tissue removal system of Fig. 1; Figs. 22 (a) through 22 (e) are several views of another alternative tissue removal device that can be used in the tissue removal system of Fig. 1 (the vacuum support not being shown in Figs. 22 (c) until 22 (e) to reveal the components positioned inside);

Fig. 23 is a fragmentary sectional view of a obturator of the present invention inserted in the introducer shown in Fig. 1;

Fig. 24 is a side view of an alternative combination of a plug and an introducer constructed in accordance with the present invention;

Figs. 25 (a) and 25 (b) are seen in disassembled and assembled side section, respectively, of another combination of a obturator and an introducer constructed in accordance with the present invention; '

Figs. 26 (a) through 26 (c) are seen in fragmentary perspective from another introducer device alternating with the “introducer device shown in Fig. 1, with the alternate introducer device being shown in partially exploded states in Figs. 26 (b) and 26 (c);

Fig. 27 is a perspective view of a second embodiment of a tissue removal system constructed in accordance with the teachings of the present invention;

Figs. 28 (a) to 28 (d) are side views in exploded bottom perspective, in exploded top perspective, partially exploded bottom and fragment, partially in section, respectively, of the morcelador assembly, shown in Fig. 27;

Figs. 29 (a) and 29 (b) are seen in upper partially exploded and lower partially exploded perspective, respectively, of the drive set shown in Fig. 27; Fig. 30 is a partially exploded fragmentary perspective view of an alternative tissue removal device that can be used in the tissue removal system of Fig. 27;

Fig. 31 (a) and 31 (b) are seen in perspective. partially exploded fragmentary of another alternative tissue removal device that can be used in the tissue removal system of Fig. 27;

Fig. 32 is a partially exploded fragmentary perspective view of another alternative tissue removal device that can be used in the tissue removal system of Fig. 27;

Fig. 33 is a partially exploded fragmentary perspective view of another alternative tissue removal device that can be used in the tissue removal system of Fig. 27;

Fig. 34 is a fragmentary sectional view of another alternative tissue removal device that can be used in the tissue removal system of Fig. 27; and

Fig. 35 is a fragmentary sectional view of another alternative tissue removal device that can be used in the tissue removal system of Fig. 27.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention is described below mainly 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 tissues. However, the devices and related procedures of the present invention can be used in a wide variety of applications throughout the body, through a variety of access routes.

For example, the devices of the present invention can be optimized for use through open surgery, with less invasive access, such as laparoscopic access, or through minimally invasive procedures such as percutaneous access. In addition, the devices of the present invention can be configured to access a therapeutic or diagnostic site through any of the body's natural openings for access through the ears, nose, mouth and transrectal, urethral and vaginal access routes.

In addition to the performance of one or more gynecological and urological procedures described in detail here, the systems, methods, devices and devices of this

| The invention can be used to perform one or more additional procedures, including, but not limited to, accessing and manipulating or removing tissue from any of a variety of organs and tissues, such as the bladder, breast, lung, stomach, intestine, esophagus, oral cavity, rectum, sinus, Eustachian tubes, heart, gallbladder, spine, shoulder, knee, pelvis, brain, arteries, veins, various ducts. Access routes include, but are not limited to, transcervical; transvaginal wall; transuterine; transvesicle; transurethral; and other routes.

Referring now to Fig. 1, a partially exploded perspective view of an embodiment of a tissue removal system is shown, the tissue removal system being constructed in accordance with the teachings of the present invention and being generally represented by the number reference 5.

System 5 is particularly suitable for the removal of uterine fibroids and other abnormal gynecological tissues. However, it should be understood that system 5 is not limited to such use and can be used in other anatomies that may be evident to people normally skilled in the art.

The system 5 may comprise a tissue removal device (or morcelador) 6, an introducer device 7, a flexible hysteroscope 8, a fluid source 9, a vacuum assembly 10 and a motor drive assembly

11.

Referring now to Figs. 2 (a) to 2 (d), the tissue removal device 6 can be seen in greater detail. The device 6 may comprise the complementary left and right support halves 13-1 and 13-2, respectively, each of which may be made of a rigid polymer or other suitable material. The halves 13-1 and 13-2 can be joined, for example, with screws 15 to form an elongated hollow support 13, comprising a rounded side wall 16, an open proximal end 17 and an open distal end 19. Support 13 can be folded or otherwise ergonomically shaped to fit comfortably in a user's hand. The proximal cap 18 can be mounted on a proximal end 17, the cap 18 being shaped to include a pair of lumens 18-1 and 18-2. The lumen 18-1 can be used to receive, for example, an external drive shaft, and the lumen 18-2 can be used to receive, for example, a vacuum tube. A distal cap 20 can be mounted on the distal end 19, the cap 20 being shaped to include a lumen, which can be used to receive, for example, a pair of coaxial cutting tubes.

A plurality of ribs 14 can be integrally formed and properly positioned along the respective interior surfaces of 13-1 and 13-2, the ribs 14 providing structural reinforcement to the support 13 and being used to align some of the mechanical components that are positioned on the support 13.

The device 6 may further comprise an internal drive axis 21 adapted for rotation around its longitudinal axis. The shaft 21, which can be an elongated unitary structure made of a sufficiently rigid metal or polymer, can be shaped to include a proximal end 23 and a distal end 25. The proximal end 23 of shaft 21 can be mounted coaxially on and fixed to the distal end 27 of an external driving shaft 29, the external driving shaft 29 being inserted through a retainer 28 mounted on the support 13.

In this way, the rotation of the shaft 21 can be mechanically coupled to the rotation of the shaft 29. The distal end 25 of the shaft 21 can be inserted through an opening 30 in an annular bearing 31, whose bearing 31 can be mounted coincidentally in a rib l4-1 through a circumferential groove 32 provided in the bearing 31.

The device 6 may further comprise a translational drive axis 35 adapted to rotate around its longitudinal axis.

Shaft 35, which can be an elongated unitary structure made of suitably rigid metal or polymer, can be shaped to include a proximal end 37, an intermediate portion 39 and a distal end 41. The proximal end 37 of shaft 35 can be mounted coaxially over and fixed to the distal end 25 of the internal drive shaft 21. In this way, the rotation of the axis 35 can be mechanically coupled to the rotation of the axis 21. The intermediate portion 39 can be shaped to include a double helix portion comprising a channel helical threaded clockwise 42 and a helical threaded counterclockwise 43. Helical channels 42 and 43 can have identical or different slopes, but preferably have identical slopes.

Helical channels 42 and 43 can easily be joined at their respective ends to form a continuous groove, so that there can be a smooth transition from one helical channel to the other.

The distal end 41 of the shaft 35 can be suitably dimensioned to be received in an opening 44 in an annular bearing 45, the bearing 45 of which can be coincidentally mounted on a rib 14-14 through a circumferential groove 46 provided in the bearing 45.

It should be noted that, although axis 35 is adapted for rotation, axis 35 is stationary in translation.

The device 6 may further comprise a gear assembly 50 adapted for rotation about its longitudinal axis.

The gear assembly, 50, which can be an elongated unitary structure made of a suitably rigid metal or polymer, can be shaped to include a proximal toothed gear 51 and a portion of the distal tube 52. The gear assembly 50 can be mounted coaxially on the intermediate portion 39 of the axis 35 in an area between the double helix portion and the distal end 41, and the gear assembly 50 can be fixed to the axis 35 with a pin inserted radially through the portion of the tube 52 and within a opening provided in the shaft 35. In this way, the rotation of the toothed gear 51 can be mechanically coupled to the rotation of the shaft 35. The device 6 can also comprise an oscillating translation set 61. The translation set 61, in turn, can comprise a carriage 62 and a channel hitch member 63. The carriage 62, which may be a unitary structure made of a suitably rigid metal or polymer, may be shaped to include a proximal portion 64 , an intermediate portion 65 and a distal portion 66. The tops of the proximal portion 64 and distal portion 66 may extend beyond the top of the intermediate portion 65 and may be shaped to include handles 67-l and 67-2, respectively, handles 67-1 and 67-2 being aligned with each other.

A longitudinal hole 68-1 can be provided near the bottom of the carriage 62, hole 68-1 being suitably dimensioned to receive the intermediate portion 39 of the axis 35 coaxially, while allowing the intermediate portion 39 to rotate freely therein.

The channel 63 engagement member, which can be a unitary structure made of a suitably rigid metal or polymer, can be shaped to include a base 69 and a tongue 70. The base 69 can be placed in an opening 68-2 that can be extend downwards from the top of the intermediate portion 65 in communication with the hole 68-1, with the tongue 70, the tongue moving within the double helix portion of the axis 35. In this way, as the axis 35 rotates, the tongue 70 can continuously move back and forth through the double helix portion of the axis 35, thus causing the carriage 62 to oscillate translationally.

As can be seen, the speed at which the carriage 62 oscillates translationally can vary, for example, by varying the translation length of the double helix portion of the axis 35, the angles of channels 42 and 43, the rotation speed of the axis 29, etc. As will be discussed later, it may be desirable to operate device 6, so that the carriage 62 oscillates translationally at about 2.8 cycles / second.

The device 6 may further comprise an axis 72 adapted to rotate about its longitudinal axis. The shaft 72, which can be an elongated, unitary, tubular structure made of a suitably rigid metal or polymer, can be shaped to include a proximal portion 72-1 and a distal portion 72-2. The proximal portion 72-1 can be inserted through the handles 67-1 and 67-2 of the carriage 62 and can rotate freely in relation to the handles 67-1 and 67-2. The distal portion 72-2 may be in the form of an elongated toothed gear. The distal portion 72-2 can be engaged with the toothed gear 51 of the gear assembly 50, so that rotation of the toothed gear 51 causes rotation of the shaft 72. The distal portion 72-2 can be elongated so that it holds the engagement with the toothed gear 51 even as the distal portion 72-2 moves in translation mode in relation to the toothed gear 51. The speed at which the distal portion 72-2 rotates (and therefore the speed at which the shaft 72 turns) can be equal to or different from the speed at which the toothed gear 51 rotates, depending, for example, on the relative diameters of the two gears (the ratio of the rotation speeds of the two gears being inversely proportional to the ratio of the diameters of the two gears) . Consequently, by properly dimensioning the toothed gear 51 and the distal portion 72-2, a desired rotation speed can be achieved, even where the rotation speed of the external drive shaft is fixed.

For example, in the modality shown, the distal portion 72-2 has a diameter that is a quarter of the diameter of the toothed gear 51 and therefore rotates four times faster than the gear 51. Therefore, if the external driving shaft has a rotation speed of about 1500 rpm, gear 51 could rotate at 1500 rpm and distal portion 72-2 could rotate at 6000 rpm.

As can be seen, the speed of rotation of the distal portion 72-2 does not depend on the interaction of the translation set 61 with the double helix portion of the axis 35; consequently, the distal portion 72-2 can achieve higher or lower rotation speeds than would be possible based on the requirements of a desired translation speed.

Notwithstanding the above, the shaft 72 is coupled translationally to the carriage 62. Consequently, as the carriage 62 oscillates in translation, so does the shaft 72. The device 6 may further comprise a strain relief member 74, which can be a unitary tubular structure made of a polymer or rigid metal.

The proximal end of the strain relief member 74 can be fixedly mounted on a retainer 75, which can be mounted on the distal end of the support 13, with the distal end of the strain relief 74 extending distally from the support 13 for a short distance , as,

for example, about 2 inches.

The device 6 may further comprise a cutting mechanism.

In the present embodiment, the cutting mechanism may comprise an outer tubular member 76 and an inner tubular member 77, the inner tubular member 77 moving in rotation and, at the same time, oscillating in translation relative to the outer tubular member 76 in the form a described below.

The outer tubular member 76, which may be a unitary structure made of stainless steel or other similarly suitable material, may be shaped to include an open proximal end, a closed distal end 81 and a lumen 82 extending from the open proximal end 79 to a point just before the closed distal end 81. The member 76 can be mounted coaxially on the strain relief member 74, with the proximal end of the member 76 arranged on the proximal end of the strain relief member 74 and with the distal end 81 of the member 76 extending distally beyond the distal end of the strain relief member 74 over an extended distance, such as, for example, five inches. The proximal end of the member 76 can be attached to the retainer 75.

ES The outer tubular member 76 can be further shaped to include a resection window 89 in which the tissue can be captured and pulled, the window 89 being located near the distal end 81, such as, for example, 0.25 inch from the distal end 81. Window 89 can be shaped to include a proximal end 89-1 and a distal end 89-2. The proximal end 89-1 can gradually tilt closely, and the distal end 89-2 can gradually tilt distally. More specifically, the window 89 can be approximately 0.55 inch long, the proximal end 89-1 can be a radial end with a radius of curvature of, for example, 0.085 inch, and the distal end 89-2 can be a radial end having a radius of curvature of, for example, 0.150 inch. Window 89 can extend over a substantial portion of the circumference of the tubular member 76, such as, for example, about 60% of the circumference.

The outer tubular member 76 may have an outside diameter of less than about 5.5 mm. However, in order to reduce the risk of injury to the patient, and in order to avoid the need for administration of anesthesia to the patient, the outer tubular member 76 preferably has an outer diameter of less than about 5 mm, more preferably less than 4 mm, even more preferably less than 3 mm, and even more preferably less than 2 mm. However, device 6 should be used in an operating room environment where general anesthesia is available, so the diameter of the external tubular member 76 could be increased to maximize tissue removal. In such a case, the outer tubular member 76 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, the outer tubular member 76 could be constructed with an outside diameter of at most about 9 mm, in some applications less than about 8 mm, preferably less than 7 mm, and more preferably less than than 6 mm where OD is desirably minimized.

The inner tubular member 77, which can be an elongated unitary structure made of stainless steel or other similarly suitable material, can be shaped to include a proximal end 91, a distal end 92 and a longitudinal lumen 93. The distal end

92 can be shaped to include an external chamfer, such as, for example, an external chamfer of approximately 20 degrees. An intermediate length of the tubular member 77 can be coaxially received on the axis 72 and can be fixedly coupled to the axis 72 for the translation and rotation movement therewith. The proximal end 91 of the tubular member 77 can be slidably mounted on a vacuum tube connector 95, which can in turn be coupled to a vacuum tube 393, inserted through the lumen 18-2 of the cap 18. A ring O-shaped 96 can be mounted within connector 95 to maintain a good seal with tubular member 77. An annular bearing 98 mounted within support 13 can be used to receive tubular member 77 and to maintain its alignment.

Tubular members 76 and 77 can be arranged so that, when tubular member 77 is in a fully retracted (i.e., proximal) position, the distal end 92 of tubular member 77 can be removed sufficiently to allow the tissue to enter the window 89 (preferably with the distal end 92 of the tubular member positioned close to window 89), and so that when the tubular member 77 is in a fully advanced (i.e., distal) position, the distal end 92 of the tubular member 77 can be positioned distally from the distal end 89-2 of window 89. In this way, as the tubular member 77 is moved translationally and in rotation beyond window 89, the fabric in window 89 can be cut.

To promote such a tissue cut, the outer diameter of the inner tubular member 77 may be only slightly smaller (for example, about 0.002 inches) than the inner diameter: of the outer tubular member 76. It has been shown that the thermal energy created by the Contact of the rotating inner tube 77 and outer tube 76 can lead to abrasions, where the two tubular members merge.

To mitigate the risk of abrasions, the outer surface of the inner tube 77 was covered with a low friction and low abrasion coating (i.e., Titanium Nitride). Alternatively, the coating can be carried on the inner surface of the outer tube 76. The coating can have a Rockwell C hardness of at least about 50, preferably at least about 60 and, in some devices, at least about 70. The device 6 may further comprise an indicator sleeve 98. The sleeve 98, which can be an elongated tubular member made of a material that is easily visually distinguishable from the strain relief member 74, can be mounted coaxially on the strain relief member 74 and fixedly mounted on it, with a proximal end

98-1 of the glove 98 being flush against the distal end of the holder 13. An example of a material suitable for use as a glove 98 may be a white or colored vacuum-packed material.

The glove 98 can be dimensioned so that when the device 6 is inserted into the introducer device 7, the distal end 98-2 of the glove 98 is visible to a user until the distal end 81 of the device 6 advances beyond the distal end of the introducer 7. In other words, the distal end 98-2 can be used to indicate when the distal end 81 of the device 6 is flush with the distal end of the introducer 7. In this way, a user can safely control the position of the distal end of the device 6 and therefore keep it inside the introducer 7 when inserting device 6 in a patient, thereby reducing the risk of lacerations and perforations during the introduction of device 6. Referring now to Figs. 3 through 7, the introducer 7 can comprise a support 121. The support 121, in turn, can comprise a half of the left handle 123 and a half of the right handle 125, which can be molded or otherwise manufactured from rigid polymer or other suitable material and can be joined by a plurality of screws 127. Instead of being joined by

31 i screws 127, half of the left handle 123 and half of the right handle 125 can be joined with a suitable adhesive, deformable pins or they can be joined by welding by ultrasound or otherwise. The half of the left handle 123 and the half of the right handle 125 together define a hollow pistol-shaped structure comprising a handle portion 129 and a drum portion 131. The handle portion 129 can be shaped to include an aperture 133 provided in its lower end 134, and an opening 135 provided along its distal face 136, near the lower end

134. A groove 133-1 can be provided in the middle of the right handle 125, the groove 133-1 extending from the opening 133 to the drum portion 131 for a short distance. The drum portion 131 can be shaped to include an opening 137 provided at its proximal end 138 and an opening 139 provided at its distal end 140. In addition, the drum portion 131 can be shaped to include a transverse opening 141 provided in the middle of the right loop 125 at an intermediate location between the proximal end 138 and the distal end 140.

The inner surfaces of the half of the left handle 123 and the half of the right handle 125 can be shaped to include complementary sets of ribs (not shown). Such ribs can provide structural reinforcement to half of the left handle 123 and half of the right handle 125 and can help to maintain the correct positioning and alignment of the components positioned in the. support 121.

The introducer 7 can further comprise a collector 145. Collector 145, which can be molded or otherwise made from a rigid polymer or other suitable material, can be a unitary branched structure molded to include a main tubular member 147 and a lateral tubular member 149. The main member 147 can comprise a proximal end 151, an open distal end 153, a side wall 155 and a longitudinal lumen 157. The proximal end 151 of the main member 147 can be shaped to include an upper opening. 159 of comparatively larger diameter and a lower aperture 161 of comparatively smaller diameter. The side member 149 can comprise an open proximal end 163, an open distal end 165, a side wall 167 and a longitudinal lumen 169. The lumen 169 of the side member 149 can be in fluid communication with the lumen 157 of the main member 147 through the distal end open 165.

The collector 145 can be coupled to the support 121 using a pair of pins 171 and 173 that can extend from a side wall 155 and that can be received in the hollow reliefs 175 and 177, respectively, provided on the inner faces of the half of the left handle 123 and half of the right handle 125, respectively. With the collector 145 thus coupled to the support 121, the proximal end 151 of the collector 145 can be positioned in the portion of the drum 131, with the side wall 155 fitting firmly in the opening 139 and with the distal end 153 of the collector 145 extending distally by a short distance beyond the distal end 140.

The introducer 7 may further comprise a strain relief member 181. Stress relief member 181, which may be molded or otherwise made from a rigid polymer or other suitable material, may be a unitary tubular structure shaped to include an open proximal end 183, an open distal end 185, a side wall 187 and a longitudinal lumen

189. The strain relief member 181 can be partially inserted into the lumen 157 of the collector 145 and can be firmly adjusted inside the lumen 157 and fixedly attached to it using a suitable or similar adhesive, with the proximal end 183 of the relief member strain relief 181 being positioned only distally from the open distal end 165 of the lateral limb 149 and with the distal end 185 of the strain relief member 181, extending a short distance distally beyond the distal end 153 of the main limb 147. The introducer 7 can further comprise a sheath 191, which is also shown separately in Fig. 8. Sheath 191, which can be extruded or otherwise manufactured from a suitable polymer, such as nylon 12, can be a rigid unit molded structure to include a proximal end 192, a distal end 193 and a side wall 194. Sheath 191 can be further shaped to include a plurality of longitudinal lumens of fixed shape and size, such lumens including an upper lumen 196, a lower lumen 197 and a pair of lateral lumens 198-1 and 198-2. As will be discussed later, the upper lumen 196 can be used as an instrument lumen, the lower lumen 197 can be used as a display lumen, and the side lumens 198-1 and 198-2 can be used as delivery lumens. inflow fluid. (Openings (not shown) can be provided on the side wall 194 near the distal end 193, so that such side openings communicate fluidly with the side lumens 198-1 and 198-2, for example, to dispense part of the supply of fluid. inflow conducted distally by the lateral lumens 198-1 and 198-2).

The proximal end 192 of the sheath 191 can be partially inserted into the lumen 189 of the strain relief member 181 and can be firmly fitted to the lumen 189 and fixedly attached to it using a suitable adhesive or the like, with the proximal end 192 of the sheath 191 leveled with the proximal end 183 of the strain relief member 181 and with the distal end 193 of the sheath 191 extending distally beyond the distal end 185 of the strain relief member 181 by several inches.

The sheath 191, which is preferably the only component of the introducer 7 that must be inserted into a patient, can be sized to have an outer diameter of about 5.5 mm, with the lumen 196 having a diameter of about 3 mm , the lumen 197 having a diameter of about 2 mm, and the lumens 198-1 and 198-2 having a diameter of about 1.33 mm each. It can also be established that the ratio of the outside diameter to the working channel is an exemplary metric of the introducer's efficiency. It can be seen that the optimal ratio would be about 1.0, preferably not more than about 2.1, and more preferably not more than about 1.9. In the case provided here, the ratio of these diameters is about 1.83, while predicate systems have ratios of 2.25. Thus dimensioning sheath 191, if sheath 191 is inserted through a patient's cervix,

the risk of injury to the patient and the need to administer anesthesia to the patient can be minimized. However, it should be understood that the dimensions above for sheath 191 are merely exemplary and may vary depending on how the introducer 7 is used.

The introducer 7 may further comprise an instrument guide assembly mounted on the support 121 to provide a continuous channel aligned with the lumen 196 into which the tissue removal device 6 can be inserted. The instrument guide assembly may comprise a guide body

201. The body 201, which can be shaped or otherwise made from a rigid polymer or other suitable material, can be a tubular unitary structure shaped to include a proximal portion 203, a distal portion 205 and an intermediate portion 207. The intermediate portion 207 can be reduced in terms of internal diameter and external diameter in relation to the proximal portion 203 and the distal portion 205, so that the annular base 208 is formed within the body 201 at the junction of the intermediate portion 207 and the distal portion 205. The inner surface of the body 201 can taper from the proximal portion 203 to the intermediate portion 207, to facilitate the insertion of the device 6 into the intermediate portion 207 and to limit the extent to which the device 6 can be inserted into the body 201 The body 201 can be firmly fitted into the opening 137 of the support 121 and fixedly attached to it using a suitable or similar adhesive, with the distal portion 205 and the intermediate portion 2 07 of the body 201 being positioned in the drum portion 131 of the support 121 and with the proximal portion 203 of the body 201 extending through opening 137 and continuing for a short distance beyond the proximal end 138 of the support 121.

The instrument guide assembly may further comprise a glove 211. Glove 211, which can be molded or otherwise made from a rigid polymer or other suitable material, can be a unitary branched structure molded to include a tubular member main member 213 and a lateral tubular member 215. The main member 213 may comprise an open proximal end 216, one. open distal end 217 and a longitudinal lumen 219. The proximal end 216 of main member 213 can be shaped to be firmly fitted to the distal portion 205 of body 201 and can be attached to it using a suitable adhesive. The side member 215 may comprise an open proximal end 220, an open distal end 221 and a longitudinal lumen 223. The lumen 223 of the side member 215 may be in fluid communication with the lumen 219 of the main member 213 through the open proximal end 220. The distal end 221 of the side member 215 can extend through the opening 141 provided in the middle of the right handle 125 of the support 121 and can be coupled to a valve 228. The valve 228 can be an actively controlled valve, such as a regulating valve, or a passively controlled valve, such as a spring-activated ball valve.

The valve 228 can be connected at its outlet end to a length of tubing (not shown), as well as to a fluid receptacle (not shown), for conduction, as well as the collection, for example, of outlet fluid that passes through valve 228, for example, when device 6 is not present inside introducer 7. The instrument guide assembly may further comprise a combination of seal 231 and valve 233. Seal 231 and valve 233 may be members elastomeric firmly positioned between the base 208 of the body 201 and the proximal end 216 of the sleeve 211 (see Fig. 9). The seal 231, which may be located proximally to the valve 233, may include a central opening 235. The opening 235 can be appropriately sized so that when the device 6 is inserted through it, the fluid cannot readily pass through it the seal

231 around the outside of the device 6. The valve 233, which can be shaped to include a dome having a cross groove in Its upper part, can be designed so that, in the absence of the device 6 being inserted through it, the liquid cannot easily pass through it.

The instrument guide assembly may further comprise a tube 241. The tube 241, which may be a rigid hypotube made of stainless steel or the like, may comprise a proximal end 243 and a distal end 245. The proximal end 243 can be fixedly mounted within of lumen 219 of glove 211 using a suitable adhesive or the like. The distal end 245 of the tube 241 can be tightly fitted inside the lumen 196 of the sheath 191 and can be fastened therein using a suitable adhesive or the like.

The introducer 7 may further comprise a display guide assembly mounted within the support 121 to provide a continuous channel aligned with the lumen 197 into which the hysteroscope 8 can be inserted. The display guide assembly may comprise a guide body 251. The body 251, which can be molded or otherwise made from a rigid polymer or other suitable material, can be a unitary tubular structure shaped to include a portion proximal 253 of comparatively larger diameter, a distal portion 255 of comparatively smaller diameter, and an intermediate portion 257 tapering in diameter from proximal portion 253 to distal portion 255. Body 251 can be disposed within the portion of handle 129 of the holder 121, with the proximal portion 253 spaced inwardly by a short distance from the opening 133 and with the distal portion 255 facing the drum portion 131. The proximal portion 253 can be firmly fitted between and fixedly attached to the half of the left handle 123 and half of the right handle 125 of the support 121 using adhesive or other suitable means.

As will be discussed further below, the proximal portion 253 can be appropriately sized to receive the proximal portion of the hysteroscope 8, with the intermediate portion 257 of the body 251 being appropriately sized to serve as an obstacle to limit the extent to which the hysteroscope 8 can be inserted into the body 2514. An annular base 258 can be provided within the distal portion 255 and can be spaced closely in relation to the distal end 259 of the distal portion 255. The display guide assembly may further comprise a guide connector 261. The guide connector 261, which can be shaped or otherwise made from a rigid polymer or other suitable material, can be a unitary tubular structure shaped to include a comparatively larger proximal portion 263, a comparatively smaller distal portion 265 , and an intermediate portion 267 tapering in diameter from the proximal portion 263 to the distal portion 265. The p proximal orifice 263 can be shaped to be tightly fitted within the distal portion 255 of body 251 and can be attached to it using a suitable adhesive.

The display guide assembly may further comprise the combination of a seal 271 and a valve 273. The seal 271 and valve 273 can be elastomeric members firmly positioned between the base 258 of the body 251 and a proximal portion 263 of the connector 261. The seal 271, which may be located close to valve 273, may include a central opening suitably sized so that when hysteroscope 8 is inserted through it, fluid cannot readily pass through seal 271 around the outside of the hysteroscope 8. Valve 273, which can be shaped to include a dome having a cross slot in Its upper part, can be designed so that, in the absence of the hysteroscope 8 being inserted through it, the fluid cannot readily pass through it.

The display guide assembly may further comprise a tube 281. Tube 281, which may be a flexible unitary member made from a suitable polymer or other material, may comprise a proximal end 283, a distal end 285 and a lumen 286. The proximal end 283 can be fixedly mounted within the distal portion 265 of the connector 261 using a suitable adhesive or the like. The distal end 285 of the tube 281 can be firmly fitted within the lumen 197 of the sheath 191 and can be fixed within it using a suitable adhesive or the like. The lumen 286 can be appropriately sized so that the distal portion of the hysteroscope 8 can be inserted into it and thus guided by tube 281 to lumen 197.

The introducer 7 may further comprise a mechanism for reversibly coupling the hysteroscope 8 to the display guide assembly. This mechanism can comprise a cam lock 291. The lock 291, which can be manufactured from a rigid polymer or other suitable material, can be a unitary structure molded to comprise a lever 292 and a support point 293. The contact point support 293 can be pivotally mounted on support 121 using a rotating pin 294 inserted through a transverse opening 295 at the support point 293 and securely received at its opposite ends in the openings 296 and 297 provided in the middle of the left handle 123 and in the middle of the handle right 125, respectively. The fulcrum 293 may comprise a face 298 adapted to engage frictionally to the proximal portion of the hysteroscope 8 when the lever 292 is rotated towards the portion of the loop 129.

The introducer 7 can further comprise a tube 301. The tube 301, which can be manufactured from a suitable polymer or other material, can be a flexible unitary structure shaped to include a proximal end 303 and a distal end 305. The proximal end 303 can be attached to the distal end of a connector fit 307 firmly mounted inside opening 135 of the bracket

121. The distal end 305 can be positioned within the lumen 169 of the collector 145 and can be fixed in place using an adhesive or other suitable means. As will be discussed later, The connector setting 307 can be connected to the fluid supply outlet 9, In this way, the fluid dispensed through the setting 307 and inside the tube 301 can be guided by the tube 301 to the collector

145. Thereafter, the fluid in the manifold 145 can flow distally through lumens 198-1 and 198-2 of sheath 191.

Again referring to Fig. 1, hysteroscope 8, which can be, for example, a conventional flexible hysteroscope, can comprise a proximal portion 311 and a distal portion 313. The proximal portion 311, which can be comparatively rigid, of compact length and of wide diameter, it can comprise an entrance door 315, an exit door 317 and a distal end 318. The distal portion 313, which can be comparatively flexible, elongated in length and narrow in diameter, can comprise a distal end 319. The hysteroscope 8 can be appropriately sized so that the distal end 318 of the proximal portion 311 can be received in the body 251, with the distal portion 313 extending distally through the seal 27i, valve 273, connector 261, tube 281 and lumen 197, and with the distal end 319 positioned at or a short distance beyond the distal end 193 of the sheath 191. Although not present in the embodiment shown, the portion pr oximal 311 of hysteroscope 8 can be provided with chamfers or other physical characteristics that can be used to join with or otherwise engage with cam lock 291. The distal end 319 of hysteroscope 8 can be constructed to allow viewing of objects, such as at angles of O, 15 or degrees, in relation to the longitudinal axis of the distal portion

313. In this way, when placing the hysteroscope 8 in a certain angular orientation, the hysteroscope 8 can be used to see the functioning of the distal end of the device 6. Such an angular orientation can be ensured through the orientation of the hysteroscope 8 so that the door inlet 315 is aligned with and extends to slot 133-1.

The fluid supply 9 can comprise a syringe containing fluid, a peristaltic pump or other suitable fluid dispensing device, having an outlet end 321 which can be coupled to the fitting of connector 307. The fluid supply 9 can comprise automated means ( not shown) for dispensing the inlet fluid at a desired rate.

Vacuum assembly 10 can include a sample collection container 391 and a vacuum source 392. The distal end of an evacuation tube 393 can be connected to the proximal end of the vacuum tube connector 95, and the proximal end of the tube evacuation valve 393 can be coupled to a first container door 394

391. The distal end of a tube 395 can be coupled to a second port 396 of container 391, and the proximal end of tube 395 can be coupled to the vacuum source

392. In this way, the vacuum source 392 can be used to apply suction to device 6, and all tissue, liquids or similar material removed, sucked through device

6, can be collected in container 391. The motor drive assembly 11, which can be coupled to an electricity source, such as an AC wall outlet, using a power cord (not shown),. it can include a support 397, in which electronic devices (not shown) and a motor (not shown) can be placed. A 398 pedal can be attached to the motor drive assembly by a 398-1l chain and can be used as a power switch to selectively activate or deactivate the motor.

The proximal end of the shaft 29 can be mechanically coupled for rotation to the motor, and the distal end of the shaft 29 can be inserted through the opening 18-1 in the mounting block 18 and coupled to the inner shaft 21 in the manner described above.

A protective sheath 399 can cover much of the length of shaft 29. The drive assembly of the motor 11 can also include a vacuum sensor 400, which can be coupled to the container 391 by a pipe 401, so that the pressure inside the container 391 can be monitored.

In this way, a sudden increase in the vacuum pressure may indicate that an obstruction has occurred.

The presence of an obstruction can be indicated by an alarm (not shown) located on support 397. The detection of an obstruction is generally a clear indication that the additional operation of the device 6 can only aggravate the clogging situation and that an interruption removal of tissue may be necessary. The motor drive assembly 11 can be configured to synchronize the motor drive with the vacuum source 392 drive. In this way, starting the motor will turn on the vacuum source 392 at the same time. Correspondingly, the vacuum source 392 can be deactivated whenever the engine is stopped.

In use, the distal end 319 of the hysteroscope 8 can be inserted first through the introducer guide guide channel 7, then through the collector 145, and then through the lumen 197 of the sheath 191. With the hysteroscope 8 thus inserted in the introducer 7, cam lock 291 can be used to secure the proximal portion 311 of hysteroscope 8 to the introducer 7. The input end 315 and the output end 317 of hysteroscope 8 can then be coupled to a light source and camera, respectively . Alternatively, the camera can be omitted, and the output end 317 can be seen directly with the naked eye. The fluid supply 9 can then be coupled to the connector fitting 307 of the introducer 7. The end 193 of the sheath 191 can then be inserted transcervically, that is, through the vagina and cervix, into the patient's uterus.

Before introducing the distal end 193 of sheath 191 into the patient, the cervix can be gradually dilated in the conventional manner using obturators of increasing diameter.

The uterus can then be washed out of blood and other debris that may be present, by dispensing fluid from the power supply 9 into the introducer 7, said fluid then being able to exit the introducer 7 distally through the lumens 198-1 and 198-2. The valve 228 can be opened during this washing procedure, so that the fluid and any debris present in the uterus can leave the uterus proximally through the lumen 196 of the sheath 191 and, subsequently, it can leave the introducer 7 passing through the tube 241. , inside the main member 213 of the sleeve 211, through the side member 215 of the sleeve 211, and through the valve 228. When the washing procedure is finished, the valve 228 can be closed, while the fluid can continue to be dispensed inside the uterus through lumens 198-1 and 198-2, thus causing the uterus to be distended by the fluid.

When the uterus becomes sufficiently distended by such fluid, valve 228 can be opened, while fluid can continue to be delivered into the uterus.

In this way, the uterus can be maintained in a desired degree of distension, while the fluid is continuously circulated through the uterus. With the uterus then dilated with the fluid, the hysteroscope 8 can be used to examine the inside of the uterus.

If abnormalities are detected that a person wishes to remove, the tissue removal device 6 can be loaded into the introducer 7, that is, by inserting the distal ends of the outer tubular member 76 and the inner tubular member 77 distally through the ”channel guide of instrument of the introducer 7 and then through channel 196 of sheath 191, with the support 13 remaining external to the patient. The device 6 can then be manipulated so that the window 89 of the outer tubular member 76 can be positioned close to the fibroid or other targeted tissue. Then, the vacuum source 392 can be operated so as to cause suction to be applied to the inner tubular member 77, thus pulling the fabric into the outer tubular member 76 through the window 89. In addition, the motor of the assembly of The drive of the motor 11 can be driven, thus causing the inner tubular member 77 to simultaneously rotate and oscillate back and forth in translation within the outer tubular member 76, resulting in the fabric being pulled through the window 89, being cut. The cut tissue can then be aspirated from the patient through the internal tubular member 77, by means of the aforementioned suction, and subsequently collected in the 391 container. Once the fibroids or other target tissues have thus been removed from the patient, the source of vacuum 392 and the engine can be turned off, device 6 can be removed from introducer 7, and introducer 7 can be removed from the patient.

Device 6 can be designed to be a single use device.

If so, device 6 can then be disconnected from the evacuation tube 393 and the flexible driving shaft 398-2 and disposed of properly.

It should be noted that, although the discussion above contemplates the use of introducer 7 to introduce device 6 into the uterus, a person - can insert device 6 transcervically into the uterus without the use of introducer 7. In such a situation, the fluid may be administered transcervically to the uterus by a fluid dispensing device in order to distend the uterus and, subsequently, observation of the uterus can be performed, for example, by ultrasound image using an ultrasound probe inserted transcervically into the uterus.

Such an ultrasound probe can be separated from or integrated with device 6.

Alternatively, visualization of the uterus can be performed by means of magnetic resonance imaging.

Although one or more of the rotational movement speeds of the internal tubular member 77 can be varied, the frequency of oscillation of the translational movement of the internal tubular member 77, the rate of advance of the internal tubular member 77 (that is, the ratio of the speed in the which the tubular member 77 oscillates in translation at the speed at which the tubular member 77 rotates) and the suction magnitude provided by the vacuum source 392, particularly good results were obtained under the following conditions: rotational speed of the tubular member 77 - at least 1100 rpm, more preferably at least 5000 rpm, even more preferably approximately 6000 rpm; oscillation frequency of translational movement of the tubular member 77 - at least 1.5 cycles / second, more preferably about 2.5 to 4 cycles / second, even more preferably about 2.8 cycles / second; rate of advance preferably less than 0.25, more preferably less than 0.15; and vacuum pressures in the range of 200 to 650 mmHg. Preferably, the above parameters are selected to achieve a tissue removal rate of at least 1.5 g / min, while the outer tubular member 76 has an outer diameter of no more than about 3.0 mm.

As can be seen, as suction is applied to the inner tubular member 77, some of the distension fluids located in the uterus may be accidentally removed from the uterus through the inner tubular member 77. This loss of uterine distention fluid may be undesirable, if it interferes with keeping the uterus in a properly stretched state. Preferably, System 5 is constructed and operated in such a way that, with an excess vacuum of 300 mmHg, a volume at a rate not exceeding about 300 ml / min of fluid is removed. This may involve, for example, the application of suction only at specific times, for example, only when the motor responsible for moving the internal tubular member 77 is activated or closing the resection window 89 with the internal tubular member 77 each time the motor control is stopped.

In general, morcellators can be constructed according to the present invention as having a smaller outside diameter or cross-section profile than current commercial products, such as the Smith & Nephew Hysteroscopic Morcellator, but at the same time performing a higher rate of tissue resection . In addition, morcellators according to the present invention can be operated at a significantly higher vacuum, while managing the total fluid flow within acceptable limits.

For example, the cross-sectional area of the suction lumen in the morcellators according to 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 suction lumen will not be greater than about 8.0 square millimeters, and, for certain applications, the area will not be greater than about 7.5 square millimeters.

The rate of tissue resection is generally at least about 1.5 g / min, and often at least about 1.8 g / min. In certain embodiments, the rate of tissue resection is at least about 2.0 g / min, and, in a certain embodiment, 2.2 or more g / min.

Morcellators according to the present invention can be constructed to have a fluid use of no more than about 350 ml / min. In certain embodiments, the use of fluid of no more than about 300 ml / min or no more than about 275 ml / min can be constructed.

The vacuum applied to the morcellators of the present invention will generally be in the range of about 200 to about 650 mmHg. The morcellator will normally be operated in a vacuum of at least about 350 mmHg and, often, of at least about 500 mmHg.

Ss4 Fn a modality of the present invention, the cross-sectional area of the suction lumen was about 7.1 mm ?, and resulted in a tissue resection rate of about 1.4 g / min, under vacuum of approximately 600 mmHg .

In general, the procedures performed 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, the total fluid (eg, saline) introduced into the uterus will generally not be greater than about 12 liters, and preferably not greater than about 10 liters or 8 liters. The distension fluid will preferably be kept at a low enough pressure and a short enough time to keep the total intake of saline in the vessels below 2.5 liters.

In a typical procedure according to the present invention, when using a morcellator having an external diameter of 3 mm, the fluid flow rate for aspirating saline solution through the morcellator is approximately 260 ml / min (for example, inside from about 240 to about 280 mi / min). Thus, in a ten-minute procedure, approximately 2.6 liters of saline are aspirated through the morcellator. In that same procedure, the rate of tissue resection is typically in excess of about 2 g / min.

In a comparative experiment, a device manufactured in accordance with the present invention was compared to the performance - of an alternative hysteroscopic morcellator from Smith and Nephew. In a series of experiments “as a declared device, the vacuum was maintained on average in the range of 200 to 270 mmHg, the speed of the morcellator was approximately 1100 rpm, the rate of tissue resection was approximately 1.4 g / min, the fluid flow rate through the die was approximately 247 ml / min, and the outside diameter of the die was 4.0 mm. : The device constructed in accordance with the present invention was operated at a vacuum of 600 mmHg, a speed of about 6000 rpm, to produce a resection rate of approximately 2.2 g / min and an aspiration flow rate of approximately 266 ml / min through the morcellator. The external diameter of the device was 3 mm.

The morcellator according to the present invention thus produced a significantly higher resection rate, through a smaller diameter diameter morcellator, at a grossly comparable flow rate of aspirated saline. In order to increase the rate of resection of the declared device, the vacuum must be significantly increased. For example, when the vacuum pressure in the declared system was increased to about 670 mmHg, the tissue cut improved to 3.5 g / min, but the fluid flow rate jumped to 540 ml / min.

A challenge with the increased flow rate that is sensitive to the higher vacuum is that the replacement fluid must be infused at the procedure site at an equal rate.

In order to infuse the fluid at a rate sufficient to allow the declared device to operate at a higher vacuum, the diameter of the largest declared morcellator must be increased.

Depositors have determined that the use of the morcellator disclosed in this document, with an external diameter of no more than about 3 mm, in combination with the optical system, allows cervical dilation to be limited to no more than about 5.5 mm.

It is believed that the increase in the diameter of the morcelador to accommodate the higher infusion rate, as well as the already larger external diameter of the declared system, crosses the pain threshold and seems to impose the need or convenience to perform the procedure under general anesthesia.

Depositors believe that this is a significant benefit for many patients so that they are able to avoid general anesthesia.

Referring now to Figs. 1i0 (a) and 10 (b), views are shown of fragmented longitudinal sections of certain alternative inner tubular members that can be used in the tissue removal device 6. An alternative first inner tubular member is shown in Fig. 10 (a) and is generally represented by the reference numeral 411. The inner tubular member 411 may be similar in some respects to the inner tubular member 77; However, a notable difference between the two tubular members is that, while the inner tubular member 77 can be a unitary structure made from a single piece of material, the inner tubular member 411 can be formed by joining two separate pieces of material. material.

More specifically, the inner tubular member 411 may comprise a first piece in the form of a proximal rod 413 and a second piece in the form of a distal tip 415, with the distal tip 415 preferably having a length greater than the length of the viewing window. resection 89 and, more preferably, having a length of less than about 2 inches and, in a certain construction, about 1 inch.

The proximal stem 413 and the distal tip 415 can be made of the same material or can be made of different materials.

Comparatively hard stainless steel materials, such as 400 series stainless steels (for example, 440C stainless steel), where hardness exceeds Rockwell C values of around 50, are preferred for the distal tip 415, as these materials allow a much sharper edge at the distal tip 415 to be created.

On the other hand, less hard stainless steel materials, such as 300 series stainless steels (for example, 304 stainless steel), may be preferable for the proximal stem 413, since these materials can be formed comparatively inexpensively in long tubular structures, for example, by extrusion, while 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. The proximal rod 413 and the distal tip 415 can be joined by welding or other suitable techniques.

Any of a variety of window and cutting edge configurations can be used, depending on the desired performance, including any of those disclosed in U.S. Patent Application Serial No. 12 / 098,250, deposited on April 4, 2008 to Gruber, et al., The description of which is hereby incorporated by reference in its entirety.

Another notable difference between tubular member 411 and tubular member 77 is that, while tubular member 77 may have a uniform inner diameter over its length, The inner diameter of the distal tip 415 can be reduced compared to the inner diameter of the rod proximal 413

: (for example, 0.082 inch x 0.085 inch). Depositors believe that this increase in the internal diameter from the distal tip 415 to the proximal stem 413 may result in a reduction in the incidence of clogging in the tubular member 411 since the cut sample, which has an external diameter similar to the distal tip 415 , moves from the distal tip 415 into the proximal stem 413, which has a larger diameter than the sample. This clearance on the proximal stem 413 facilitates the proximal movement of the sample through the tubular member 411.

A second alternative inner tubular member is shown in figure 10 (b) and is generally represented by reference numeral 421. Tubular member 421 may be similar in some respects to tubular member 411, the main difference between the two tubular members being that the tubular member 421 can be a unitary structure made from a single piece of material, which can be, for example, a 17-7 series stainless steel. To form tubular member 421 from a tubular structure having a uniform inner diameter, a person can first mold or roll the distal end of the tubular structure to reduce the inner diameter of the distal end, and then can increase the inner diameter of the remainder of the structure by mechanical polishing,

chemical expansion or pickling ..

Referring now to Fig. 11, a side view of an alternative indicator glove 431 is shown which can be used in the tissue removal device 6. Indicator glove 431 can be similar in many respects to indicator glove 98, the main difference between the two indicator gloves and the glove 431 can be supplied with marked or unmarked gradations 433 along its length to indicate the distance between each gradation and a distal end 431-1 of the uva 431. Since the glove 431 is preferably dimensioned and positioned so that the distal end 431-1 of the sleeve 431 indicates when the distal end 92 of the device is aligned with the distal end of the introducer 7, the gradations 433 indicate the relative distance between the distal end 92 of the device 6 and the distal end of the introducer 7. Gradations 433 may comprise, for example, numerical markings, symbols, hatch marks, rings or the like.

Referring now to Fig. 12, there is shown a fragmentary side view, partly in section, of an alternative combination of a tissue removal device and an introducer that can be used in the tissue removal system 5, said tissue removal device. removal of tissue being generally represented by reference numeral 441 and said introducer being generally represented by reference numeral 443. Device 441 and introducer 443 can be similar in many respects to device 6 and introducer 7, respectively , the main differences being that the device 441 may include, instead of the sleeve 98, a position indicator ring 445 fixedly mounted on the strain relief member 74, and the introducer 443 may include, instead of the proximal portion 203 of the body 201 , a proximal portion 447 appropriately shaped to provide just enough interference with impacts 445-1 and 445-2 on ring 445 so that a tactile indication that the ring can be given 445 is being inserted in the proximal portion 447.

Referring now to Figs. 13 (a) and 13 (b), fragmentary side views are shown, partly in section, of another alternative combination of a tissue removal device and an introducer that can be used in the tissue removal system 5, said tissue removal device 5. removal of tissue being represented in general by reference numeral 451 and said introducer being represented in general by reference numeral 453.

The 451 device can be identical to the device

441. Introducer 453 can be similar in many respects to Introducer 7, the main difference between the two introductors being that Introducer 453 can be shaped to include a 455 sound chamber and can also include a clip or 457 spring clip. clamp 457 can have a fixed end 457-1 which is mounted within the sound chamber 455 and a free end 457-2 which is constructed to be tilted by ring 445 when ring 445 moves distally after clamp 457, A tilting the clamp 457 through the ring 445 causes the clamp 210 457 to oscillate and generate an audible signal.

Referring now to Fig. 14, a fragmentary side view is shown, partly in section, of an alternative tissue removal device that can be used in the tissue removal system 5, said tissue removal device being represented in general by the reference numeral 470. Certain aspects of the device 470 are not important for an understanding of the invention, nor are they shown or described here.

The 470 device can be similar in many | aspects to the device 6, the main differences between the two devices being that, while the device 6 may comprise a rotation mechanism comprising a toothed gear 51 engaged with a distal gear-shaped portion 72-2 of an axis 72, the device 470 may instead comprise a rotation mechanism comprising an axis 472 comprising a distal tubular elastomeric portion 472-2 engaged for rotation with an elastomeric O-ring 474 mounted firmly within a groove 476 of a cylindrical member 478 fixedly coupled to the axis translation engine 35.

Referring now to Figs. 15 (a) and 15 (b), views are shown in fragmentary perspective and in exploded perspective, respectively, of another alternative tissue removal device that can be used in the tissue removal system 5, said tissue removal device being generally represented by the reference numeral 500. Certain aspects of the device 500 are not important for an understanding of the invention and are neither shown nor described here.

The device 500 can be similar in many respects to the device 6, a difference between the respective tissue removal devices in that the device 500 can comprise a mounting bracket

501. The support 501, which can be a unitary structure made of a rigid metal or polymer, can be shaped to include a base portion 503, a proximal block 9505 extending upwardly from the proximal end of the base portion 503 , a distal block 507 extending upwardly from the distal end of the base portion 503, and an intermediate block 509 extending upwardly from an intermediate portion of the base portion 503. Another difference between the device 500 and device 6 is that, while device 6 may comprise an internal driving shaft 21, a translating driving shaft 35 and a gear assembly 50, device 500 may instead comprise an internal driving shaft 510, a driving shaft travel adapter 511 and a gear assembly 512. The internal drive shaft 510, which may be an elongated unitary structure made of a suitably rigid metal or polymer, can be shaped to include a proximal end 513 and an end distal ade 515. The proximal end 513 of the shaft 510 can be mounted coaxially on and fixed to the distal end of the external driving shaft 29. In this way, the rotation of the shaft 510 can be mechanically coupled to the rotation of shaft 29. An intermediate portion of the shaft 510 can be received inside a longitudinal hole 520 in the block 505 of the support

501. The gear assembly 512 can be fixedly mounted on the distal end 515 of the shaft 510, in order to 'rotate with the shaft 510. The gear assembly 512 may include a proximal toothed gear of larger diameter 523 and a distal toothed gear of smaller diameter 525.

The translational drive shaft 511, which may be a unitary elongated structure made of a suitably rigid metal or polymer, may be shaped to include a proximal end 537, an intermediate portion 539 and a distal end 541. The proximal end 537 of the axis 511 it can be in the form of a toothed gear, which can be engaged with the distal gear 525. In this way, the rotation of the shaft 511 can be mechanically coupled to the rotation of the shaft 510, with the rotation speed of the shaft 511 being dependent on the speed of rotation. rotation of the shaft 510 and the relative sizes of the gear 525 and the proximal gear 537. The intermediate portion 539 can extend through a longitudinal hole 509-1 provided in the block 509 of the support 501. The intermediate portion 539 can be molded to include a double helix portion 540 similar to the double helix portion of shaft 35. The distal end 541 of shaft 511 can be suitably sized to be received within a opening 544 provided in block 507 of support 501. It should be noted that, although axis 511 is adapted for rotation, axis 511 is stationary in translation.

Another difference between device 500 and device 6 is that, while device 6 may comprise an axis 72 mechanically coupled to the inner tubular member 77, in order to rotate and oscillate in translation with it, device 500 may, instead, comprise an elongated shaft 551 mechanically coupled to the inner tubular member 77 so as to rotate and oscillate in translation with it, shaft 551, which can be a unitary tubular structure made of a rigid metal or polymer, can be shaped to include a toothed gear engaged with proximal gear 523. The gear can be elongated so that it can maintain engagement with proximal gear 523 even when the gear moves in translation relative to proximal gear 523. The speed at which axis 551 rotates can be equal to or different than the speed at which gear 523 rotates, depending, for example, on the relative diameters of the two gears (the ratio of the rotation speeds of the two gears ns being inversely proportional to the ratio of the diameters of the two gears). Consequently, by the appropriate dimensioning of the gears, a desired rotation speed can be achieved, even where the rotation speed of the external drive shaft is fixed.

For example, in the embodiment shown, the shaft gear 551 may have a diameter that is one third of the diameter of gear 523 and therefore rotate three times faster than gear 523. At the same time, the proximal end 537 of the shaft 511 can have a diameter that is four-thirds the diameter of gear 525 and therefore rotates three-quarters faster than gear '525. So if the external drive shaft has a rotation speed of about 2000 rpm, the 551 shaft (and the inner tubular member 77) would rotate about 6000 rpm and the 511 axis would rotate about 1500 rpm, which, with proper molding of the double helix portion of the 511 axis, could be used to achieve a translational oscillation speed for the internal tubular member 77 of approximately 2.8 cycles / second.

Referring now to Fig. 16, a fragmentary side view of an alternative tissue removal device that can be used in the tissue removal system 5 is shown, said tissue removal device being represented in general by the reference numeral 570. Certain aspects of the 570 device that are not important to an understanding of the invention are neither shown nor described here.

The device 570 can be similar in many respects to device 6. A difference between the two devices may be that, while device 6 can fix the internal driving shaft 21 to the external driving shaft 29 for rotation with it and can couple the rotation of the limb inner tubular 77 to the inner driving shaft 21 by engaging the shaft 72 and gear 51, the device 570 can instead fix the inner tubular member 77 to the outer driving shaft 29 for rotation with it and can couple the rotation of the inner drive shaft 21 to inner tubular member 77 by engaging a toothed gear pair 572 and 574. Gear 572 can be coaxially inserted over and attached to inner tubular member 77, and gear 574 can be coaxially inserted over and secured to the internal driving shaft 21. Gears 572 and 574 can be sized to be, for example, in a ratio of 1: 4, respectively, so that if the external driving shaft 29 rotates at about 6000 rpm, the member internal tubular 77 also rotates at about 6000 rpm, while the internal drive shaft 21 rotates at about 1500 rpm.

Referring now to Fig. 17, there is shown a fragmentary side view of an alternative tissue removal device that can be used in the tissue removal system 5, said tissue removal device being represented in general by the reference numeral 580.

Certain aspects of the 580 device that are not important for understanding the invention are neither shown nor described here.

The device 580 can be similar in many respects to device 6. A difference between the two devices may be that, while device 6 can fix internal drive shaft 21 to external drive shaft 29 for rotation with it and can couple the rotation of the inner tubular member 77 to the inner driving shaft 21 through the engagement of the shaft 72 and gear 51, the device 580, instead, can couple the rotation of the inner driving shaft 21 to the outer driving shaft 29 through the engagement of a pair of gears gears 582 and 584 and can couple the rotation of the internal tubular member 77 to the external driving shaft 29 by engaging a toothed gear 586 with the gear 582. The gear 582 can be coaxially inserted over and fixed to the external driving shaft 29, the gear 584 can be coaxially inserted over and fixed to the internal driving shaft 21, and gear 586 can be coaxially inserted over and fixed to internal tubular member 77. Gears 582 and 584 can be dimensioned geared to be, for example, in a ratio of 1: 2, respectively, and gears 582 and 586 can be sized to be, for example, in a ratio of 2: 1, respectively.

Thus, if the external driving shaft 29 rotates at about 3000 rpm, the internal tubular member 77 will rotate at approximately 6000 rpm and the internal driving shaft 21 will rotate at approximately 1500 rpm.

Referring now to Fig. 18, a fragmentary perspective view of an alternative tissue removal device that can be used in the tissue removal system 5 is shown, said tissue removal device being represented in general by the numeral of reference 600. Certain aspects of the device 600 that are not important for understanding the invention are neither shown nor described here.

The device 600 can be similar in many respects to device 6. A difference between the two devices can be their respective mechanisms for alternative rotation and translation of the internal tubular member

77. More specifically, device 600 may comprise an internal driving shaft 603 attached to an external driving shaft (not shown), so as to rotate with it. The internal driving shaft 603 can comprise a proximal portion 605 and a distal portion 607. A toothed gear 609 and a chamfered gear 611 can be mounted coaxially on the distal portion 607 and attached to it for rotation with the same, with the chamfered gear 611 being positioned distally in relation to the toothed gear

609. A toothed gear 613 can be coaxially mounted on the inner tubular member 77 and attached to it for rotation with it, to the gear 613 being engaged with the gear 609 so that the rotation of the internal driving shaft 603 causes: rotation of the member internal tubular 77.

(The speed of rotation of the inner tubular member 77, compared to that of the driving shaft 603, can be controlled by the relative diameters of gears 609 and 613). A chamfer gear 615, positioned distally from the internal driving shaft 603, can be engaged with the chamfer gear 611. A saddle 619 can be coaxially mounted on the inner tubular member 77, the saddle 619 being attached to the inner tubular member 77 for the translational movement with it, but allowing tubular member 77 to rotate freely within it.

Saddle 619 and bevel gear 615 can be coupled to each other by a pin (not shown) extending upwards from the top surface 621 of gear 615 and a groove (not shown) provided on the bottom surface of saddle 619, the groove in the saddle 619 receiving the pin in the bevel gear 615. The groove in the saddle 619 can be oriented perpendicular to the longitudinal axis of the inner tubular member 77 and can be appropriately sized so that the pin in the bevel gear 615 moves forward and to back into the groove in the saddle 619 as the bevel gear 615 rotates.

In this way, the rotation of the gear - chamfered 615 can cause oscillation in translation of the internal tubular member 77. Referring now to Fig. 19, a fragmentary perspective view of an alternative tissue removal device that can be used in the tissue removal system 5, said tissue removal device being generally represented by reference numeral 700. Certain aspects of device 700 not important for understanding the invention are neither shown nor described here. The device 700 can be similar in many ways to the device 6. A difference between the two devices can be their respective mechanisms for alternative rotation and translation of the internal tubular member 77. More specifically, the device 700 can comprise a fixed internal driving shaft 703 to an external driving shaft (not shown), in order to rotate with it. A toothed gear 705 and a travel cam 707 can be coaxially mounted on the drive shaft 703 and attached to it for rotation as same, with the travel cam 707 being positioned distally with respect to toothed gear 705. A toothed gear 711 can be mounted coaxially on the inner tubular member 77 and fixed to it for rotation as same, gear 711 being engaged with gear 705 so that the rotation of the inner driving shaft 703 causes the rotation of the inner tubular member

77. (The speed of rotation of the internal tubular member 77,

when compared to that of the driving shaft 703, it can be controlled by the relative diameters of gears 705 and 711). A saddle 713 can be mounted coaxially on the inner tubular member 77, the saddle 713 being attached to the inner tubular member 77 for translation movement with it, but allowing tubular member 77 to rotate freely within it. The saddle 713 and the translation cam 707 can be coupled together by a pin (not shown) extending downwards from the saddle 713 and a groove in the handle 717 provided in the cam 707, the groove 717 receiving the pin in the saddle. 713. The groove 717 in the cam 707 can be shaped to extend from approximately the proximal end .707-l of the cam 707 to approximately the distal end 707-2 of the cam 707 and back to approximately the proximal end 707-1 of the cam 707 during a rotation of the cam 707. In this way, as the cam 707 rotates and the pin moves back and forth inside the groove 717, the inner tubular member 77 can be swiveled in translation, correspondingly.

Referring now to Fig. 20, a fragmentary perspective view of an alternative tissue removal device that can be used in the tissue removal system 5 is shown, said tissue removal device being generally represented by the numeral of

. 74 reference 800. Certain aspects of the device 800 that are not important for understanding the invention are neither shown nor described here. Device 800 can be similar in many ways to device 6. A difference between the two devices can be their respective mechanisms for alternate rotation and translation of the internal tubular member

77. More specifically, device 800 may comprise an internal driving shaft 801 attached to an external driving shaft (not shown), in order to rotate with it. A toothed gear 803 can be coaxially mounted on the drive shaft 801 and attached to it for rotation with it. In addition, a travel cam 805 can be coaxially mounted on the drive shaft 801 and attached to it for rotation with it. The translation cam 805 can comprise a tubular portion 805-1 and a disc portion 805-2, the disk portion 805-2 being fixedly mounted on the tubular portion 805-1 at a non-perpendicular angle relative to the longitudinal axis of the tubular portion 805-2. A toothed gear 813 can be coaxially mounted on the inner tubular member 77 and attached to it for rotation with it, gear 813 being engaged with gear 803 so that the rotation of the inner driving shaft 801 causes the rotation of the inner tubular member 77. (The speed of rotation of the inner tubular member 77, when compared to that of the driving shaft 801, can be controlled by the relative diameters of gears 803 and 813). A saddle 819 can be coaxially mounted on the inner tubular member 77, the saddle 819 being attached to the inner tubular member 77 for the translation movement with it, but allowing the tubular member 77 to rotate freely within it.

The saddle 819 can be shaped to include a recess 821, which can receive the top of the disk portion 805-2. In this way, as the driving shaft 801 rotates, causing the disk portion 805-2 to "swing" back and forth, the saddle 819 and, therefore, the inner tubular member 77, can swing in translation correspondingly.

Referring now to Fig. 21, a fragmentary perspective view of an alternative tissue removal device that can be used in the tissue removal system 5 is shown, said tissue removal device being generally represented by the reference numeral 900. Certain aspects of the 900 device that are not important to an understanding of the invention are neither shown nor described here.

The 900 device can be similar in many respects to the device 6. A difference between the two devices can be their respective mechanisms for alternate rotation and translation of the internal tubular member

77. More specifically, device 900 may comprise an internal driving shaft 901 attached to an external driving shaft (not shown), in order to rotate with it. A toothed gear 903 and a threaded gear 905 can be coaxially mounted on the drive shaft 901 and attached to it for rotation with it. A toothed gear 907 can be mounted coaxially on the inner tubular member 77 and attached to it for rotation with it, gear 907 being engaged with gear 903 so that rotation of the inner driving shaft 901 causes the rotation of the inner tubular member 77, (The rotation speed of the inner tubular member 77, compared to that of the driving shaft 901, can be controlled by the relative diameters of gears 903 and 907). A threaded gear 911 can be engaged with threaded gear 905 so that threaded gear 911 rotates as threaded gear 905 rotates. A pin 913 can be mounted near the periphery of a front façade 911-1 of the threaded gear 911. A shuttle arm 15 can have a first end attached to pin 913 and a second end attached to a block 917 coupled in translation to the tubular member internal 77. In this way, as the threaded gear 911 rotates and the position of the pin 913 in the threaded gear 911 changes, the arm 915 moves the block 917 and the internal tubular member 77 back and forth in translation.

As can be seen,. it would be desirable to minimize the amount of distention fluid flowing from the patient's uterus through the tissue removal device when the tissue removal device is left on the patient, but the cutter motor for the tissue removal device has been temporarily turned off, for example, 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 because at least the reason that the distention fluid that is lost will have to be replaced in order to keep the uterus distended.

In device 6, this problem can be addressed through electronic devices that detect when the engine for device 6 is about to be turned off and, in these cases, by positioning the inner tubular member 77 in relation to the translational outer tubular member 76, so that the resection window 89 is closed.

An alternative approach to this problem is exemplified by the tissue removal device 940, which is shown in Figs. 22 (a) to 22 (e). Certain aspects of the 940 device that are not important for an understanding of the invention are neither shown nor described here.

Device 940 is similar in certain respects to device 6. However, a difference between the respective devices is that device 940 can comprise an internal tubular member 943 having a

5. closed proximal end 945 and a side window 947. A spring support 949 can be mounted coaxially on the inner tubular member 943 and attached to it for rotation with it.

The proximal end of a spring 951 can be attached to the spring support 949, and the distal end of the spring 951 can be attached to a valve member 953 coaxially mounted on the inner tubular member 943, the valve member 953 being able to rotate with respect to the inner tubular member 943. The valve member 953 may include a side window 955. The side window 955 may be alignable with the side window 943, depending on the respective rotation positions of the inner tubular member

943 and valve member 953. An obstacle 957 can be formed on the inner tubular member 943, the obstacle 957 being detachably engageable with valve member 953 to couple the rotation of the member with valve member 953 with the inner tubular member 943. One vacuum support 959 can be mounted coaxially on valve member 953, valve member 953 being freely rotatable within vacuum support 959. External tubular member 76 can be fixedly mounted on vacuum support 959. A pair of rings in The 961-1 and 961-2 can be supplied to function as seals.

Before the cutting motor of device 940 is activated, side window 955 of valve member 953 and side window 947 of inner tubular member 943 are misaligned 90 degrees with each other. However, once the cutting motor of device 940 is activated, the inner tubular member 2943 begins to rotate. This causes spring 951 to try to relax, causing valve member 953 to rotate so that side window 955 of valve member 953 is aligned with side window 947 of inner tubular member 943. With valve member 953 thus rotationally aligned with the inner tubular member 943, the obstacle 957 prevents further rotation of the valve member 953 in relation to the inner tubular member 943. When the cutting motor of the device 940 is then switched off, the spring 951 causes the member valve 953 is rotated back to its original orientation with respect to the inner tubular member 943.

As mentioned above, introducer 7 preferably comprises valve 233, which is designed to prevent fluid from escaping from the patient when device 6 is not inserted into introducer 7. However, there may be situations where it is desirable to have fluid flowing simultaneously into and out of the patient without having the device 6 inserted in the introducer 7. Therefore, referring now to Fig. 23, a fragmentary section view of a obturator 965 positioned inside an introducer channel is shown

7. The plug 965 can be shaped to include a hard distal end 967 and a plurality of openings 969 leading to a longitudinally extending channel 971. The plug 965 can be positioned on an instrument channel 196, as shown, or can be positioned in the fluid inlet channel 198-1 or in the fluid inlet channel 198-2 to provide bidirectional fluid flow (for example, with the influx of fluid exiting channels 198-1 or 198-2 in the space between channels 198 -1 or 198-2 and the plug 965 and with the outlet fluid entering the plug 965 through the openings 969). The outlet fluid entering channel 971 through openings 969 can exit the plug 965 through the proximal end (not shown) of the plug 965.

An alternative plug 972 is shown in Fig. 24, plug 972 having a side opening 973 at an intermediate location along its length, side opening 973 being aligned with an outlet fluid channel 975 provided in an alternative introducer 977. If desired, the plug 972 can be made of a resilient member having a fold and the introducer 977 can be provided with a sheath 978 made of a flexible material. In this way, the plug 972 can be used to provide a fold to the sheath 978 which, by rotating the proximal end 979 of the plug 972, can be used to guide the distal end of the sheath 978. Referring now to Figs. 25 (a) and 25 (b), an alternative combination of a obturator and an introducer is shown, according to the present invention, the obturator being generally represented by reference numeral 980 and the introducer being generally represented by reference numeral 981 The plug 980, which may be similar in many respects to the plug 965, may comprise a distal member 982 and a proximal member 983. Distal member 982 - may be tubular and may comprise an open distal end 984, a closed proximal end 985 and a lateral opening 986, with the proximal member 983 being mounted on the proximal end 985 of the distal member

2982. Introducer 981 may be similar in many respects to Introducer 7, a difference between the respective introductors in that Introducer 981 may additionally comprise a fluid outlet channel 987. Channel 987 may comprise a distal end 987-1 that may be aligned with the side opening 986 of plug 980 when plug 980 is installed in introducer 981. In this way, the outlet fluid can flow from plug 980 to channel 987 and can come out of introducer 981 through a proximal end 987-2 channel 987. The introducer 981 may additionally comprise a 988-1 valve and a 989-2 valve. The 988-1 valve, which can be a regulating valve, can be used to control fluid flow through channel 987. The 988-2 valve, which can be a regulating valve, can be used to control fluid flow through channel 987. of the 989 inflow channel.

Referring now to Figs, 26 (a) through 26 (c), several views of an alternative introducer device to the introducer device 7 are shown, the alternative introducer device being generally represented by the reference numeral 990.

The introducing device 990 may be similar in many respects to the introducing device 7. A difference between the introducing device 990 and the introducing device 7 may be that, while the introducing device 7 may comprise a sheath 191 having an upper lumen 196, a lower lumen 197 and a pair of side lumens 198-1 and 198-2, the introducer device 990 may comprise an upper tubular member 991, a lower tubular member 992, a sleeve 993 and a distal cap 994. The upper tubular member 991 can be used , for example, as an instrument channel for receiving, for example, tissue removal device 6 or obturator 965. The lower tubular member 992 can be used, as shown, for example, to receive the distal end 319 of the hysteroscope 8. Can the glove 993, which can be made of stainless steel or similar, be adequately dimensioned to receive coaxially the upper tubular member 991 and the lower tubular member 992? and can be shaped to define a pair of fluid channels 995 on opposite sides of the tubular members 991 and 992 in the spaces between the inner surface of the sleeve 993 and the outer surfaces of the tubular members 991 and 992. provided in glove 993, near distal end 997 thereof, with openings 996 providing lateral access to fluid channels 995. In this way, the influx of fluid into the patient can be provided through the distal passage of fluid through channels 995 and , then, radially out through the 996 openings. The patient's fluid outlet can travel proximally through the 99% cap and then proximally through the upper tubular member 991 (for example, by passing through an instrument positioned on the limb upper tubular 991). It is believed that the fluid flow pattern provided by the 990 introducer device can be particularly effective in removing blood and other unwanted fluids from a patient. The cap 994 can include a retainer 998, which can receive the distal ends of the tubular members 991 and 992 and which can be inserted into and attached to the distal end 997 of the sleeve 993.

Referring now to Fig. 27, a partially exploded perspective view of a second embodiment of a tissue removal system is shown, the tissue removal system being constructed in accordance with the teachings of the present invention and being generally represented by reference numeral 1007.

The system 1007 can comprise a tissue removal device 1008, a vacuum assembly 1009 and a motor drive assembly 1010. Although not shown in the present embodiment, the system 1007 can also include an introducer device, a flexible hysteroscope and a fluid supply similar to those of system 5 described above.

The tissue removal device 1008 may comprise a morcelador assembly 1013 and a mounting unit 1015, the assembly of morcelador 1013 being removably mounted on the assembly unit 1015 in the manner described below.

Referring now to Figs. 28 (a) to 28 (d), the assembly of the morcelador 1013 can be seen in greater detail. The assembly of the morcelador 1013 can comprise a support 1021. The support 1021, which can be an elongated unitary structure made of a polymer or rigid metal, can in general be a tubular member shaped to include a proximal end 1023, a distal end 1025 and a side wall 1027. Side wall 1027 can be generally cylindrical, with a portion 1028 of its lower surface being chamfered. A longitudinal lumen 1029 can extend from the proximal end 1023 to the distal end 1025. An intermediate portion 1031 of the lumen 1029 can be expanded in diameter and can be accessed through an opening 1033 in the side wall 1027. A proximal portion 1035 of the lumen 1029 extending distally from the proximal end 1023 to a point closely spaced from the intermediate portion 1031 can be expanded in diameter and can be internally threaded.

The assembly of the morcelador 1013 can additionally comprise a pair of tubular bearings 1041 and 1043. The bearing 1041, which can be a unitary structure made of a polymer or rigid metal, can be seated within the intermediate portion 1031 of the lumen 1029, close to its proximal end, and can be fixedly fastened to support 1021 with screws 1042. Bearing 1043, which can be a unitary structure made of a polymer or rigid metal, can be seated within the intermediate portion 1031 of the lumen 1029, near its distal end , and can be fixedly attached to bracket 1021 with screws 1044. Bearing 1041 can be shaped to include a hole 1045, and bearing 1043 can be shaped to include a hole 1047, holes 1045 and 1047 being coaxially aligned with lumen 1029 support 1021.

The assembly of the morcelador 1013 may further comprise a 105% elongated shaft. The shaft 1051, which may be a unitary structure made of brass or another suitable rigid metal or polymer, may be shaped to include a proximal portion 1053, a distal portion 1055, an intermediate portion 1057 and a longitudinal hole 1059, The proximal portion 1053 of the shaft 1051 can be slidably mounted in the hole 1045 of the housing 1041 and can be dimensioned to rotate freely within it. The distal portion 1055 of the shaft 1051 can be slidably mounted in the hole 1047 of the bearing 1043 and can be dimensioned to rotate freely within it. The intermediate portion 1057 of the shaft 1051 can be positioned between the bearings 1041 and 1043 and can be in the form of a gear with an enlarged external diameter in relation to the proximal portion 1053 and the distal portion 1055. The assembly of the morcelador 1013 can also comprise a translational coupling block 1061. Block 1061, which may be a unitary structure made of a rigid polymer or metal, may be a tubular member shaped to include a proximal end 1063, a distal end 1064, a side wall 1065 and a hole longitudinal

1066. The block 1061 can be mounted coaxially on the proximal portion 1053 of the axis 1051, with the hole 1066 being dimensioned in relation to the proximal portion 1053, so that the. proximal portion 1053 can rotate freely inside the hole

1066. The side wall 1065 of the block 1061 can be shaped to generally correspond to the shape of the intermediate portion 1031 of the lumen 1029. In this way, the block 1061 can be held rotationally stationary within the support 1021. The block 1061 can be fixed in translation with respect to axis 1051 with a retaining ring 1067 coaxially inserted over the proximal portion 1053 and attached to the proximal portion 1053 with a fixing screw 1068. A washer 1069 can be inserted coaxially over the proximal end 1053 of the axis 1051 between the distal end 1063 of block 1061 and the intermediate portion 1057 of the axis 1051 to avoid any wear caused by contact of the intermediate portion 1057 against the distal end 1063 of the block 1061 as the intermediate portion 1057 rotates.

The side wall 1065 of the block 1061 can further be molded to include a waist 1070 of reduced outer diameter.

In this way, with the block 1061 coaxially mounted on the proximal portion 1053 of the axis 1051, a pair of grooves 1071-1 and 1071-2 can be formed between the block 1061 and the support 1021. The assembly of the morcelador 1013 can also comprise a strain relief member 1072. Strain relief member 1072, which may be a unitary structure made of a polymer or rigid metal, may be a tubular member shaped to include a proximal portion 1073 and a distal portion 1074. The proximal portion 1073 may be slightly larger in diameter than the distal portion 1074, and may include a bifurcated groove 1075. The proximal portion 1073 of the strain relief member 1072 may be arranged within the distal portion of the lumen 1029, with the distal portion 1074 of the strain relief member 1072 extending distally from the distal end 1025 of the support 1021 by a short distance, such as, for example, about 2 inches.

The assembly of the morcelador 1013 may further comprise a cutting mechanism.

In the current embodiment, the cutting mechanism may comprise an outer tubular member 1076 and an inner tubular member 1077, the inner tubular member 1077 moving rotationally and, at the same time, oscillating in translation in relation to the outer tubular member 1076 in the form to be described later.

The outer tubular member 1076, which may be a unitary structure made of stainless steel or other similarly suitable material, may be shaped to include an open proximal end 1079, a closed distal end 1081 and a lumen 1083 extending from the open proximal end 1079 to a point just before the closed distal end 1081. The member 1076 can be mounted coaxially within a strain relief member 1072, with the proximal end 1079 of the member 1076 disposed within the proximal portion 1073 of the strain relief member 1072 and with the distal end 1081 of the member 1076 extending distally beyond the distal portion 1074 of the strain relief member 1072 over an extended distance, such as, for example, five inches.

The combination of the proximal end 1079 of the member 1076 and the proximal portion 1073 of the strain relief member 1072 can be securely retained in the bracket 1021 using a screw 1085 inserted through an opening 1087 in the bracket 1021, the screw 1085 pressing the portion proximal 1073 of the strain relief member 1072 firmly against the proximal end 1079 of the member 1076. The outer tubular member 1076 can be further shaped to include a resection window 1089 where the tissue can be captured and pulled, to window 1089 being located close to the distal end 1081, such as 0.25 inch from the distal end 1081. Window 1089 can be shaped to include a proximal end 1089-1 and a distal end 1089-2. The proximal end 1089-1 can gradually tilt proximally, and the distal end 1089-2 can gradually tilt distally.

More specifically, window 1089 can be approximately 0.55 inch long, proximal end 1089-1 can be a radial end with a radius of curvature of, for example, 0.085 inch and distal end 1089-2 can be a radial end having a radius of curvature of, for example, 0.150 inch.

Window 1089 can extend over a substantial portion of the circumference of the tubular member 1076, for example, about 60% of the circumference.

The outer tubular member 1076 may have an outer diameter of less than approximately 5.5 mm. However, in order to reduce the risk of injury to the patient and, in order to avoid the need for anesthesia to be administered to the patient, the outer tubular member 1076 preferably has an outer diameter of less than about 5 mm, more preferably smaller at 4 mm, even more preferably less than 3 mm, and even more preferably less than 2 mm.

The inner tubular member 1077, which can be an elongated unitary structure made of stainless steel or other similarly suitable material, can be shaped to include a proximal end 1091, a distal end 1092 and a longitudinal lumen 1093. The distal end 1092 can be shaped to include an external chamfer, such as an external chamfer approximately 20 degrees. An intermediate portion of the tubular member 1077 can be received inside the hole 1059 of the axis 1051 and can be fixedly coupled to the axis 1051 for the translation and rotation movement with it using a retaining ring 1094-1, a sleeve with a groove 1094-2 and a pair of 1095 fixing screws. The proximal portion of ring 1094-1 can be screwed to the distal end of shaft 1051, with the distal portion of ring 1094-1 extending over member 1077. Sleeve 1094-2 can be be inserted coaxially between member 1077 and ring 1094-1, and fixing screws 1095 can be inserted through a transverse opening 1096 in retaining ring 1094-1 to couple ring 1094-1 and sleeve 1094-2 to the limb 1077. Tubular member 1077 may be of adequate length so that, when tubular member 1077 is in a fully retracted (i.e., proximal) position, the proximal end 1091 of tubular member 1077 can extend proximally a short distance from the proximal end 102 3 of the support 1021 and the distal end 1092 of the tubular member 1077 can be removed sufficiently to allow the fabric to enter the window 1089. At the same time, the tubular member 1077 can be of a length so that when the tubular member 1077 is in a fully advanced (i.e., distal) position, the distal end 1092 of tubular member 1077 can be positioned distally from the distal end 1089-2 of window 1089. The assembly of the morcelador 1013 may further comprise a 1097 socket. The 1097 socket, which it can be a unitary structure made of a polymer or rigid metal, it can be a tubular member shaped to include a proximal portion 1098, a distal portion 1099 and a longitudinal lumen 1100, The proximal portion 1098, which can be barbed, can be coupled through from a length of tube to the vacuum assembly 1009. The distal portion 1099 of the socket 1097 can be externally threaded to join with the proximal portion 1035 of the holder 1021. The lumen 1100 of the enc the socket 1097 can be sized to slide the end: proximal 1091 of the tubular member 1077. An O-ring 1101 can be arranged within the lumen 1100 to provide a seal around the tubular member 1077. Referring now to Figs. 29 (a) and 29 (b), the mounting unit 1015 can be seen in greater detail. Mounting unit 1015 may include a main body

1105. The main body 1105, which can be a unitary structure made of a polymer or rigid metal, can be a generally gutter-shaped member to include a distal end 1107, a proximal end 1109 and a side wall 1111. The distal end 1107 may be generally circular and may include a distal surface that includes a central portion 1115 and a peripheral portion

1117. The central portion 1115 can be recessed in relation to the peripheral portion 1117. A central transverse opening 1119 can be provided in the central portion 1115, and a pair of smaller transverse openings 1120 can be provided in the central portion 1115 on opposite sides of the central opening.

1119. The proximal end 1109 can be generally circular and can include a proximal surface that includes a central portion 1123 and a peripheral portion 1125. The central portion 1123 can be lowered with respect to the peripheral portion 1125. A central transverse opening 1127 can be provided in the central portion 1123, and a pair of smaller transverse openings 1129 can be provided in the central portion 1123 on opposite sides of the central opening 1127. The side wall 1111 can extend from the distal end 1107 to the proximal end 1109, but only over approximately the upper half of their respective circumferences.

A longitudinal groove 1131 can be provided along the outer surface of the side wall 1111 to receive a corresponding portion of the bracket 1021 of the morcelador assembly 1013. The groove 1131 can include a first transverse groove 1133 extending through the side wall 1111 and a second transverse groove 1135 extending through the side wall 1111. The first transverse groove 1133 can be spaced a short distance from the distal end 1107 and can generally be oriented circumferentially in relation to the side wall 1111. The second transverse groove 1135 can be spaced a short distance from the proximal end 1109 and the first transverse groove 1133 and can be generally oriented longitudinally with respect to the side wall 1111. The inner surface of the side wall 1111 can additionally be shaped to include a block 1141 located between the first groove cross-section 1133 and the second cross-section 1135. The block 1141 can be molded to include an outer groove 1143 on its bottom surface, groove 1143 extending parallel to the second transverse groove

1135. A support 1145, which can be a unitary structure made of a polymer or rigid metal, can be fixed to the bottom surface of block 1141 with a pair of screws

1146. The support 1145 can be shaped to include a groove 1147 on its upper surface, which is complementarily molded to the groove 1143, with the grooves 1143 and 1147 together defining a channel in a generally cylindrical manner.

The mounting unit 1015 may additionally comprise a mechanism for conducting rotational movement of the inner tubular member 1077. Such a mechanism may comprise a first motor 1151. The motor 1151, in turn, may comprise a first end 1152 having an axis 1153 extending from it. The first end 1152 can be received within the central portion 1115 of the distal end 1107 of the body 1105 and can be attached to it with screws 1156 inserted through the openings 1120 and into the complementary openings 1157 at the first end 1152 of the 1151 engine. With the engine 1151 thus fixed to the distal end 1107, the axis 1153 can extend through the central transverse opening 1119 and can rotate freely within it. 1159 cables can be used to connect the 1151 engine to the control unit

1010. In addition, the aforementioned mechanism for guiding the rotational movement of the inner tubular member 1077 may further comprise a coupling block 1161 and a gear 1162. Coupling block 1161, which may be a unitary structure made of a polymer or rigid metal, can be shaped to include a distal base 1163 and a proximal column, the proximal column extending closely from base 1163. Base 1163 can be shaped to include a cavity 1164 accessible from its distal end where shaft 1153 of motor 1151 can be received and fixed with a screw 1165, in order to mechanically couple shaft 1153 to block 1161. The proximal column can be shaped to include a distal portion 1166 of larger diameter and a proximal portion 1167 in diameter reduced. Gear 1162, which can be a unitary member made of a polymer or rigid metal, can be shaped to include a distal tube 1168 and a proximal gearwheel 1169. Tube 1168 can be mounted coaxially on portion 1166 of block 1161 and mechanically coupled to it with a screw 1170. The wheel 1169 can be 'positioned so that a portion of the wheel 1169 extends through the groove 1133 for engagement with the intermediate portion 1057 of the axle 1051. In this way, rotation of the wheel 1169 causes rotation axis 1051. The proximal portion 1167 of column 1165, which may extend a short distance beyond the wheel 1169, can be seated within a bearing 1173, the bearing 1173 being seated within the distal end of the channel defined jointly by the block 1141 and support 1145. The assembly unit 1015 may further comprise a mechanism for conducting the oscillatory translation movement of the inner tubular member 1077. Such a mechanism may comprise a second motor 1181, Motor 1181, in turn, can comprise a first end 1182 having an axis 1183 extending therethrough.

The first end 1182 can be received within the central portion 1123 of the proximal end 1109 of the body 1105 and can be attached to it with screws 1186 inserted through the openings 1129 and into the complementary openings 1187 at the first end 1182 of the 1181 engine. With the engine 1181 thus attached to the proximal end 1109, the axis 1183 can extend through the central transverse opening 1127 and can rotate freely within it. An 1189 cable can be used to connect the 1181 motor to the 1010 control unit.

In addition, the aforementioned mechanism for guiding the oscillatory translation movement of the inner tubular member 1077 may further comprise a coupling block 1191, a threaded pin 1192 and a carriage 1193. Coupling block 1191, which can be a unitary structure made of a polymer or rigid metal, can be shaped to include a proximal opening 1194 and a distal opening

1195. The proximal opening 1194 can be sized to securely receive shaft 1183 from motor 1181, thus mechanically coupling shaft 1183 to block 1191. Distal opening 1195 can be sized to securely receive the proximal end of the threaded pin 1192, in order to mechanically couple pin 1192 to block 1191, the distal end of pin 1192 can be seated within a bearing 1196 which, in turn, can be seated within the proximal end of the channel defined jointly by block 1141 and support 1145. The 1193 carriage, which can be a unitary structure made of a polymer or rigid metal, can be shaped to include a 1197 hole and a pair of tips extending upwards 1198. A 1199 rigid ring can be fixedly mounted inside the 1197 hole of the carriage 1193 using a pair of 1200 screws. Ring 1199 can be internally threaded to engage pin 1192. This way, as pin 1192 rotates, carriage 1193 moves in translation to the along the longitudinal axis of pin 1192, with the proximal or distal translation movement of the 1193 carriage effected by the clockwise or counterclockwise rotation, respectively, of the 1192 pin. The 1193 carriage can be mechanically coupled for the translation movement to the axis 1051 through the tips 1198, with the tips 1198 extending through the groove 1135 of the body 1105 and being received inside the grooves 1071-1 and 1071-2 of the assembly of the morcelador 1013. As can be seen from the description above, the speed at which the inner tubular member 1077 rotates and the speed at which the inner tubular member 1077 oscillates in translation are separately and independently controlled, with the rotation of the inner tubular member 1077 being controlled by motor 1151 and with the oscillatory translation of the inner tubular member 1077 being controlled by motor 1181. The assembly unit 1015 may further comprise a body 1201. The body 1201, which may be a unitary structure made of a polymer or hard metal, can be shaped to include a distal end 1203, a proximal end 1205, a side wall 1207, and a cavity 1208. The distal end 1203 can be generally semicircular in shape, and the proximal end 1205 can generally be of semi-annular format.

Sidewall 1207 can be semi-annular in cross section and can extend from distal end 1203 to proximal end 1205. A longitudinal groove 1209, similar in shape to groove 1131 of body 1105, can be provided along the upper outer surface side wall 1207 to receive a corresponding portion of the bracket 1021 of the morcelador assembly 1013. The cavity 1208 can be dimensioned to receive the motor 1151. A pair of longitudinal lumens 1213 can be provided in the body 1201, the lumens 1213 extending through the distal end 1203, proximal end 1205 and side wall 1207. Lumens 1213 can be aligned with corresponding threaded cavities 1215 in body 1105 so that proximal end 1205 of body 1201 can be attached to distal end 1107 of body 1105 using 1217 screws inserted through the body 1201 and in the cavities 1215. The assembly unit 1015 can also comprise a lock 1221. Lock clip 1221, which can be a unitary structure made of a polymer or rigid metal, can be shaped to include a base 1223, a pair of parallel legs 1225 and a pair of parallel feet

1227. Legs 1225 can extend upward from base 1223, with legs 1225 being spaced inwardly a short distance from the ends of base 1223. Feet 1227 can extend transversely from the legs

1225. Base 1223 can be received inside a paired shaped recess 1229 provided in body 1105 and can be fixedly retained within recess 1229, attaching body 1201 to body 1105. With the clamp 1221 thus mounted on body 1105, the legs 1225 extend upward beyond the body 1105 and can be inserted into the corresponding L-shaped grooves 1230 in the bracket 1021 of the morcelador assembly 1013. In this way, the clamp 1221 can be used to couple, reversibly and locked, the unit mounting brackets 1015 to the assembly of the morcelador 1013. More specifically, to lock the assembly unit 1015 in a locked way to the assembly of the morcelador 1013, you can insert the feet 1227 in the proximal portions 1230-1 of the slots 1230 and then slide feet 21227 distally to the distal portions 1230-2 of the grooves

1230. To decouple the mounting unit 1015 from the morcelador 1013, the feet 1227 can be slid close from the distal portions 1230-2 to the proximal portions 1230-1 and can then be removed from the grooves

1230. The assembly unit 1015 may further comprise a body 1231. The body 1231, which may be a unitary structure made of a polymer or rigid metal, may be a generally cylindrical member shaped to include a proximal end 1233, a distal end 1235 and a side wall 1237. A cavity 1239 can extend proximally to the distal end 1235, the cavity 1239 being sized to receive substantially everything except the first end 1182 and the stem 1183 of the engine

1181. A pair of longitudinal lumens 1241 can be provided in body 1231, Tumens 1241 extending through the proximal end 1233, distal end 1235 and side wall 1237, Lumens 1241 can be aligned with corresponding threaded cavities 1242 in body 1105, so that the distal end 1235 of the body 1231 can be attached to the proximal end 1109 of the body 1105 using screws 1243 inserted through the body 1231 and into the cavities 1242, a groove 1245 can extend longitudinally from the proximal end 1233 to the end distal 1235 along the upper surface of the side wall 1237. The groove 1245 can be aligned with the groove 1131 of the body 1105, in order to receive a corresponding portion of the support 1021 of the morcellator assembly 1013. The assembly unit 1015 may further comprise a end plate 1251. end plate 1251, which can be a unitary structure made of a polymer or rigid metal, can be a generally disk-shaped structure, molded to include a 1253 retention circuit in its upper part.

The retention circuit 1253 can be dimensioned to receive the proximal end of the support 1021 of the morceladora assembly 1013. A pair of openings 1255 can be provided in the end plate 1251. The openings 1255 can be aligned with the corresponding threaded cavities 1257 in the body 1231 of so that the end plate 1241 can be attached to the proximal end 1233 of the body 1231 using screws 1259 inserted through the end plate 1241 and into the cavities 1257. The mounting unit 1015 can also comprise a cover 1261. The cover 1261, which can be a unitary structure made of a polymer or rigid metal, can be in the form of "UÚ" having a proximal end 1263 and a distal end 1265. The lid 1261 can be dimensioned to complement the side walls 1111 and 1207 of bodies 1105 and 1201, respectively.

In addition, the cover

1261 can be attached to the body 1105 with a screw 1267, inserted through an opening 1269 in the cover 1261 and into a corresponding cavity 1271 at the proximal end 1109 of the body 1105 and with a screw 1273 inserted through an opening 1275 in the cover 1261 and inside a corresponding cavity 1277 at the distal end 1107 of the body 1105. In addition, the cap 1261 can be attached to the body 1201 by attaching the cap 1261 to a block 1281 using a screw 1283 and joining the block 1281 to the distal end 1203 of the body 1201 using a pair of screws 1285. Now returning to Fig. 27, vacuum assembly 1009 can include a sample collection container 1291 and a vacuum source 1292. The distal end of a 1293 evacuation tube can be inserted over the fitting 1097 and can be attached to it by a friction fit, and the proximal end of the evacuation tube 1293 can be coupled to a first port 1294 of the container 1291. The distal end of a tube 1295 can be coupled to a second port 1296 of container 1291, and the proximal end of tube 1295 can be coupled to the vacuum source

1292. In this way, the vacuum source 1292 can be used to apply suction to device 1008, and any tissue, liquids or similar material removed and sucked through device 1008 can be collected in container 1291.

The 1010 control unit, which can be coupled to an electrical source, such as an AC wall outlet, using a power cord (not shown), can include electronic devices (not shown) to control the operation of motors 1151 and 1181 using a 1298-1 cable connected to cables 1159 and 1189. A 1297 pedal can be attached to the control unit 1010 by a 1298-2 cable and can be used as a power switch to selectively activate or deactivate the 1151 engines and

1181. The control unit 1010 may also include a vacuum sensor 1299, which can be coupled to container 1291 by a tube 1300, so that the pressure inside container 1291 can be monitored by control unit 1010. In this way, a sudden increase in vacuum pressure may indicate that an obstruction has occurred. The presence of an obstruction can be indicated by an alarm (not shown), located on the control unit 1010. The detection of an obstruction is generally a clear indication that the additional operation of the 1008 device can only aggravate the clogging situation and that an interruption of tissue removal may be necessary. The control unit 1010 can be configured to synchronize the activation of the assembly unit 1015 with the activation of the vacuum source 1292. In this way, when turning on the assembly unit 1015, the vacuum source 1292 will be turned on at the same time. Correspondingly, the vacuum source 1292 can be deactivated whenever the mounting unit 1015 is switched off.

In use, the distal end of a hysteroscope can be inserted transcervically into a patient, and a suitable fluid can be conducted through the fluid inlet 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 can then be performed using the hysteroscope viewing channel. The distal ends of the outer tubular member 1076 and the inner tubular member 1077 can be inserted through a working channel of the hysteroscope in the uterus, with the rest of the 1007 system remaining close to the hysteroscope. the device 1008 can then be manipulated so that the window 1089 of the outer tubular member 1076 can be positioned in proximity to the fibroid or other target tissue. Then, the vacuum source 1292 can be operated so that the suction is applied to the inner tubular member 1077, thus pulling the tissue into the outer tubular member 1076 through the window.

1089. In addition, motors 1151 and 1181 can be operated in such a way that the inner tubular member 1077 simultaneously rotates and oscillates back and forth in translation within the outer tubular member 1076, thus causing the fabric to be pulled through of the 1089 window is cut off.

The cut tissue can then be aspirated from the patient through the inner tubular member 1077 by means of the aforementioned suction and subsequently collected in container 1291. Once the fibroids or other targeted tissues are removed from the patient, the 1292 vacuum source and motors 1151 and 1181 can be turned off, device 1008 can be removed from the hysteroscope, and the hysteroscope can be removed from the patient.

Morcelator assembly 1013 can then be separated from assembly unit 1015 and disconnected from vacuum source 1292. Morcelator assembly 1013 can be designed to be a single-use device, in which case it can be discarded after being used on a patient .

On the other hand, the assembly unit 1015 can be used on different patients before its elimination, with a different morceladora assembly 1013, preferably being used with each patient.

It should be noted that, although the discussion above contemplates the insertion of the 1008 device into the working channel of a hysteroscope, a 1008 device can be inserted transcervically into the uterus without the use of a hysteroscope.

In such a situation, the fluid can be administered transcervically to the uterus by a fluid dispensing device, in order to distend the uterus and, subsequently, the observation of the uterus can be performed, for example, by ultrasound image using an ultrasound probe. inserted transcervically in the uterus. Such an ultrasound probe can be separated from device 1008 or can be integrated into device 1008. Alternatively, visualization of the uterus can be performed by means of magnetic resonance imaging.

Referring now to Fig. 30, a fragmentary exploded perspective view of an alternative tissue removal device adapted for use in the 1007 system is shown, said tissue removal device being 'represented in general by reference numeral 1450. For simplicity and clarity, certain aspects of the 1450 device that are not important for understanding the invention are neither shown nor described here.

The device 1450 can be similar in many aspects to the device 1008, the main differences between the two devices being that the carriage 1193 and the translational coupling block 1061 of the device 1008 can be replaced with the carriage 1461 and the translating coupling block 1463, respectively, of device 1450.

The car 1461 of the device 1450 can be similar in many ways to the car 1193 of the device 1008, the main difference between the two cars being that The car 1461 can include a spring loaded pin tilted upwards 1465. The coupling block in translation 1463 of the device 1450 can be similar in many respects to the translucent coupling block 1061 of the device | 1008, the main differences between the two blocks being that (i) the translational coupling block 1463 can be molded to include a cavity 1467 adapted to receive the pin 1465 and (ii) the translational coupling block 1463 can be molded to include inclined surfaces 1469-1 and 1469-2 downwards, towards the “open end of cavity 1467 from the proximal and distal ends, respectively, of the translocating coupling block 1463. In use, the morcellator assembly, which comprises the translation block 1463, can be attached to the assembly unit, which comprises the carriage 1461, and the translation motor of the device 1008 can be driven to move the carriage 1461 in translation back and forth for a complete cycle.

Regardless of where the carriage 1461 and the translational coupling block 1463 can be initially positioned in translation relative to each other, as the carriage 1461 moves in translation over a complete cycle, pin 1465 is automatically secured as being aligned with the cavity 1467. For example, if the pin 1465 is initially positioned close to the translational coupling block 1463, as the carriage 1461 moves distally, the upper surface of the pin 1465 moves across the inclined surface 1469-1 and is, then received in cavity 1467, an advantage of this assembly is that pin 1465 and cavity 1467 do not need to be aligned with each other as the morcellator assembly and the assembly unit are connected to each other. As can be seen, due to the fact that the morceladora assembly can be a single use item while the assembly unit can be a reusable item, the pin 1465 and the cavity 1467 may not be initially aligned with each other.

Referring now to Figs. 311 (a) and 31 (b), fragmentary, partially exploded views are shown in perspective of another alternative tissue removal device adapted for use in the 1007 system, said tissue removal device being represented in general by the reference numeral 1500. For simplicity and clarity, certain aspects of the 1500 device that are not important for an understanding of the invention are neither shown nor described here.

The device 1500 may comprise a molding assembly 1513 and a mounting unit 1515. The molding assembly 1513 and the assembly unit 1515 may be similar in many respects to the molding assembly 1013 and the assembly unit 1015, respectively, the main differences between the respective morcellator assemblies and assembly units, the morcellator assembly 1513 and the assembly unit 1515 can be paired and detachable from each other through a detent 1517 in the morcelator assembly 1513 and a groove 1519 in the assembly unit 1515. Thus, when the device 1500 is to be used, holder 1517 of the morceladora assembly 1513 is preferably inserted in the groove 1519 of the assembly unit 1515, thus physically and operatively coupling the assembly: morceladora 1513 and the assembly unit 1515. O device 1500 can then be used in the same manner discussed above, together with device 1008. After the device device 1500 has been used, the morcelador assembly 1513 can be separated from the assembly unit 1515, for example, separating its respective proximal ends until the detent 1517 is removed from the groove 1519. If desired, the morcelador assembly.

1513 can then be disposed of, while mounting unit 1515 can be reused.

Referring now to Fig. 32, a fragmentary, partially exploded view is shown in perspective of another alternative tissue removal device adapted for use in the 1007 system, said tissue removal device being represented in general by the reference numeral 1600 For simplicity and clarity, certain aspects of the 1600 device that are not important for understanding the invention are not shown or described here.

The device 1600 can comprise a molding assembly 1613 and a mounting unit 1615. The molding assembly 1613 and the assembly unit 1615 can be similar in many respects to the molding assembly 1013 and the assembly unit 1015, respectively, the main differences between the respective morcellator assemblies and assembly units and the morcelador assembly 1613 and the assembly unit 1615 can be detachably attached to each other by means of hooks 1617 provided in the morcelador assembly 1613 near its distal end and the corresponding grooves 1619 provided in the mounting unit 1615 near its distal end. In addition, the assembly unit 1615 may further comprise a spring retaining member 1621 at its proximal end to engage with the proximal end of the morcelador 1613. Thus, when the device 1600 is to be used, the hooks 1617 of the morcelador assembly 1613 are preferably inserted into the grooves 1619 of the mounting unit 1615 and then the spring retaining member 1621 engages at the proximal end of the morcelador assembly 1613, to thus physically and operatively join the morcelador assembly 1613 and the assembly unit 1615 The device 1600 can then be used in the same manner discussed above, together with the device 1008. After the device 1600 has been used, the morcellator assembly 1613 can be separated from the assembly unit 1615, for example, by separating its respective ends proximal until the hooks 1617 are removed from the grooves 1619. If desired, the morceladora assembly 1613 can then be removed. er be eliminated, while the mounting unit 1615 can be reused.

Referring now to Fig. 33, a fragmentary, partially exploded perspective view of another alternative tissue removal device adapted for use in the 1007 system is shown, said tissue removal device being represented in general by the numeral of reference 1700. For simplicity and clarity, certain aspects of the 1700 device that are not important for understanding the invention are not shown or described here.

The device 1700 may comprise a molding assembly 1713 and a mounting unit 1715. The molding assembly 1713 and the mounting unit 1715 can be similar in many respects to the molding assembly 1013 and the assembly unit 1015, respectively, the main differences between the respective morcellator assemblies and the assembly units whereby (1) the morcellator assembly 1713 can be shaped to include a cavity 1717 and (ii) the assembly unit 1715 can be shaped to be removably received within the cavity 1717 of the morcelator assembly 1713 (Although not shown, the morcelador assembly 1713 and / or the assembly unit 1715 preferably includes a mechanism for releasably retaining the guide assembly 1715 inside the cavity 1717.) Thus, when the 1700 device is to be used, the assembly unit 1715 is preferably inserted into the cavity 1717 of the molding assembly 1713 until the molding assembly 1713 and the mounting unit 1715 are physically and operatively coupled to each other. The device 1700 can then be used in the same manner discussed above together with the device 1008. After the device 1700 has been used, the mounting unit 1715 can be removed from the cavity 1717 of the morcellator assembly 1713. If desired, the morcellator assembly 1713 it can then be disposed of while the 1715 mounting unit can be reused.

Although the present invention has been discussed above in the context of removing tissue from inside a patient's uterus, it should be understood that there may be situations in which it may be desirable to remove fibroids or other tissues located outside a patient's uterus or in other locations within a patient.

In such situations, it may be desirable to access the target tissue by laparoscopy.

Unfortunately, however, suction cannot simply be applied in this type of case to pull the tissue into the resection window of the device as the tissue would not be bathed in a liquid, but could simply be surrounded by air.

Therefore, according to the present invention, an approach to this problem is to offer a material suitable for the target tissue, which can then be used, with the application of suction, to create a seal to promote the suction of the target tissue inwardly. the resection window of the device.

Referring now to the

Fig. 34, a modality of a device designed for this purpose is shown, the device being generally represented by the reference numeral 1800. Certain aspects of the device 1800 that are not important for the understanding of the invention are not shown or described here.

The device 1800 may be similar in some respects to device 6. A difference between the two devices is that device 1800 may comprise an inner tubular member 1803 and an outer tubular member

1805. Inner tubular member 1803 and outer tubular member 1805 may be similar to inner tubular member 77 and outer tubular member 76, respectively, of device 6, except that (i) outer tubular member 1805 may comprise a port 1807 adapted to receive a suitable liquid or gel (for example, water, glycine, a thixotropic gel, etc.) from a source (not shown) and (ii) the inner tubular member 1803 can have an outside diameter that is about 0.005 to 0.006 inch smaller than the inner diameter of the outer tubular member 1805 (as opposed to about 0.002 inches of the device 6) to allow the liquid or gel delivered to the outer tubular member 1805 through port 1807 to be delivered to the target tissue through a window 1809 resection.

An alternative tissue removal device for device 1800 is shown in Fig. 35, said alternative tissue removal device being generally represented by reference numeral 1900. Certain aspects of device 1900 not important for understanding the invention are not shown and not even described here.

The device 1900 can be similar in many aspects to the device 6, the main difference between the two devices being that, while the device 6 can comprise the external tubular member 76, the device 1900 can comprise an external tubular member 1903. The external tubular member 1903 can be similar to the outer tubular member 76, except that the outer tubular member 1903 can be further shaped to include a channel 1905 having a proximal inlet port 1907 and a distal outlet port 1909. Inlet port 1907 can be adapted to connection to a source (not shown) to receive a suitable liquid or gel (for example, water, glycine, a thixotropic gel, etc.) The distal door 1909 can be positioned next to a 1911 resection window.

The modalities of the present invention described above are intended to be simply exemplary and persons skilled in the art must be able to make numerous variations and modifications to them 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 claims in. attachment.

Claims (1)

THE 1. Tissue removal device characterized by the fact that it comprises: an elongated external tubular body, having —a proximal end, a distal end and a lateral opening; an internal tube, elongated, positioned inside the external and movable tube to open and close the side window; at least one fabric cutting edge on the inner tube, to cut the fabric extending into the window; wherein the cutting edge has a hardness that exceeds the hardness of the inner tube material. : 2. Tissue removal device according to BR 15 claim 1, characterized by the fact that it is configured in such a way that the tissue cut by the cutting edge is removed at a rate of at least about 1.8 g / min and the outer tubular body has an external diameter of at most about 3.5 mm. . 3. Tissue removal device according to claim 1, characterized by the fact that the cutting edge has a Rockwell C hardness of at least about 50. 4. Tissue removal device according to claim 1, characterized by the fact that the tube - 2 internal has a Rockwell C hardness of at least about 40. 5. Tissue removal device according to claim 1, characterized by the fact that the cutting edge is formed by a grinding step and the inner tube is formed by a pulling step. 6. Tissue removal device according to: Claim 1, characterized by the fact that it also comprises a coating between the inner tube and the outer tube. ' 7. Tissue removal device according to Claim 6, characterized in that the coating is on an external surface of the inner tube,. 8. Tissue removal device according to Claim 6, characterized in that the coating comprises a titanium nitride alloy. A tissue removal device according to Claim 6, characterized in that the coating comprises a Rockwell C hardness of at least about 50. | | 10. Tissue removal device according to Claim 6, characterized by the fact that the 7. The coating comprises a Rockwell C hardness of at least about 60. 11. Removal device: of fabric according to Claim 6, characterized in that the coating comprises a Rockwell C hardness of at least about 70. 12. Tubular cutting element "for reciprocal axial movement within an external tubular sleeve characterized by the fact that the cutting element has an elongated tubular body having a proximal end, a distal end and a cutting tip, in which the tubular body it is formed in a pulling operation and the cutting tip is formed in a grinding operation. : 13. Tubular cutting element for movement. 15 axial reciprocal within an external tubular sleeve characterized by the fact that the cutting element has an elongated tubular body having a proximal end, a distal end and a cutting tip, where the tubular body has a Rockwell C hardness of at most about 40 - 20 and the cutting tip has a Rockwell C hardness of at least about 50. i 1/44 DA Rd from À À “R | ; S Ss VU Ss are healthy oo | IO IS PASS j A S “| e 3 S À BR Nà & | Ss ES? SS Sasha p B TT h Ss ([115M>: e | Fo)! h | SL ve "e À already TE q ô Fr SR TS JOIN À & IR O Ao o: = | S Í ão | | 3 S Ss = NS 2/24 s R V NY N Y 7 Y Y 3 Y Y R $ US AX ES ra S h EX. : 0 EA sv WE Vs (TN Y Sl Ns o »3 VA S a WE“: 8 if E SN ANAL - 4 Po Ok ”Wa EM dn NA * VAO OO ao PASO " Á 3/44 ts í | 8 Ke 0! and FTA SN Ss V A S and P and “R Es (O PRN GP Á À 4 AN a RIR OA 7 R À (= / q Y NOR E A. 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[SR “N IN THE EN ROHAN SS “WS Ss | Ss to SD TS À "B E R A) YOU N RW S a qn QN NR SR S S 'S TE Es) À É N Ss À ES: E N IAÃÉ IR S 1 S (7 NO No, 1 & | w O j DN AR S IA Ú À E s KI fe RNA, 3rd NOR S “O N À | QN “il 3 | N S SAS N S SU S x SM: Aa dl Ss | Ss RA RX £ Ri s STREET AND RANA SS to dd SIN SS || "The à SE - 7 ”SN ES 1 Es SHIS: 2 s 3 EE SER x "ES EE Es SEE At 36/44 RO S mw / S R Sd IS CANA 'SN S £ º / SR' N FIXE 7 NX Í 1 Tp Í Á NOR VAR SN Ss RN TA ENITOR à. SS SOS wo SS x N »Re) NS NS Ss S NR REVNSE: TX SS NS and NS SPSS - N“ e Ni N NS NE x NR NISTO, <Q w * X TN WO VS N BS Ff RA DS RW Ss QXTA Ne> ESA SESS SS SS AND SS Ss Í SÉOBNS SR S / ADE NR QN SS RES NOS S (JASSS Ss es RL // NA, TOR ”- a s OS NS to R CE NS xXx Wo NX FE NS WO Ox N NM & N NES OJ RB N IJ JZITS NR jf sw A ts N A Ss - A Rs: W ra => Ss is N es ON W: WS S & sos 5 NS Ss »SN N Dn Ss x &% o NS Petition 870200129638, of 10/14/2020, p. 51/197? At 37/44 PR VR 3 7 SI dB AX w / 8 a / NES 82 / SS SAS Q ENS S 8 8 ESSAS NON qn DR DAS AS XKnx UDO S NINO SS S W SS FT E RW IA as NR FP o EAN SINA S&S X Ss x LOSS SE DNS SENT to NENEN Sons PRA ASS 3 ISAIAS à Sã No Và SE NR NEN. ENHUHEU SS SS OS SA EE S / A ”on SBN XS & SNN A DNA N ESIAÇA, SRTA O N Ss S FORWARD 8 v Sy NS NS SN ST N Sd E NS v s SS) SS SN NS SEN 8 / NA À SN R s S SN S D Ss mx SD). 3 Y N RS m e. . S OS NS S E S Ns R gs SN s s S NR O "À 38/44 Rn S NS Ss NX “x 3 R à S | RS Ps x TENS = m2 [. m o: Y j | AND Õ E FAS NÚ = S / | 3 S FA | | NS As S | | Fa SS | | FA R H F = | | FA | j As) | j FAN OS | ij FAS N El & HAL s: 7 js SS THE s DD i 39/44 AT NAC (go º S: / WS and Ss FR * - = CL) Q '40/44 o S À / (Q; (= S ( N A Y V À À N À '"MD: S:) À À f À À THE S V S / WE m | À Y RARE. & CA “ :::; :! 42/44 AND Í h ”| IT'S . Í | | | AND HS o R El & s S & R m SS 'ms N. N FZ THE 3 ANA AEE (1st to. & ÂoO di E Ai j: N Y; 14 EA 8 À VE! Ss Ne da 1 S do GEN S df S ÁtLLO ' AA NS donates + “A o 44/44 8; FR ' EN. NW N À Nh SF SIN N | HUH N) Cf RN N N jk No DN NE IN S: S NINO & S NO INÃS: SOS AND NS N NA Ss NE NA &! NE RN Nº IN N N | . RN N AT THE NES 8 TO INE | Y N is NE RN N N p = ”JO ND» = Summary of the Patent for: “TISSUE REMOVAL DEVICE WITH HIGH RECIPROCITY RATE”,: A tissue removal device is described. The device includes an outer tubular body, an inner tubular body and a cutting edge on the inner tubular body. The outer tubular body includes a window, which can be opened or closed by moving the cutting edge. The cutting edge has a hardness that exceeds the hardness of the inner tube material. The cutting edge can have a Rockwell C hardness of at least about 50, while the inner tube has a Rockwell C hardness of at most about 40. The cutting edge can be formed. can be formed by a step of. Pull. The fabric cut by the cutting edge can be. 15 removed at a rate of at least about 1.8 grams per minute through the inner tube, and The outer tubular body can have an outer diameter of at most about 3.5 mm.