US-12616494-B2 - Uterine fibroid tissue removal device

Abstract

A uterine fibroid tissue removal device includes an inner tube disposed within an outer tube and configured to be translated and rotated relative to the outer tube, and a separately formed unitary distal tip member attached to a distal end of the inner tube, such that the distal tip member translates and rotates relative to the outer tube along with the inner tube, wherein a distal facing open cutting end of the distal tip member in fluid communication with an axial lumen of the distal tip member translates across a tissue resection window in a sidewall of the outer tube so as to sever tissue extending therethrough, the distal tip member axial lumen being in fluid communication with an axial lumen of the inner tube, wherein an outer diameter of the distal tip member is greater than an outer diameter of the inner tube.

Inventors

• Roy Hewitt Sullivan
• Albert Chun-Chi Chin
• Eric Karl Litscher
• William Lucas Churchill
• Ronald David Adams
• WILLIAM HARWICK GRUBER
• David Jacobs

Assignees

• HOLOGIC, INC.

Dates

Publication Date

20260505

Application Date

20240110

Claims (16)

1. 1 . A tissue removal device, comprising: a housing; an outer tube having a proximal end supported by the housing; an inner tube disposed within the outer tube; a drive shaft configured to be rotated by a motor; a first spur gear mounted coaxially over the drive shaft and fixed thereto, such that the first spur gear rotates with the drive shaft; a worm mounted coaxially over the drive shaft and fixed thereto, such that the worm rotates with the drive shaft; a second spur gear mounted coaxially over the inner tube and fixed thereto, such that the inner tube rotates with the second spur gear, wherein the second spur gear is meshed with the first spur gear; a worm gear meshed with the worm, such that rotation of the worm around a worm axis results in rotation of the worm gear around a worm gear axis perpendicular to the worm axis; and a reciprocation arm attached at one end to the worm gear and at a second end to the inner tube, such that rotation of the drive shaft causes rotation of the inner tube via the first and second spur gears and simultaneously causes reciprocating translation of the inner tube relative to the outer tube via the worm, worm gear and reciprocation arm, respectively.
2. 2 . The tissue removal device of claim 1 , wherein the inner tube is sufficiently flexible to bend in conformity with a bend in the outer tube while rotating within the outer tube.
3. 3 . The tissue removal device of claim 1 , wherein the outer tube comprises a window through a sidewall thereof and a closed distal end, the window being located proximal of the closed distal end and having a length of approximately 0.55 inches.
4. 4 . The tissue removal device of claim 3 , wherein the window extends over 60% of a circumference of the outer tube.
5. 5 . The tissue removal device of claim 1 , wherein an outer diameter of the inner tube is about 0.002 inches less than an inner diameter of the outer tube.
6. 6 . The tissue removal device of claim 1 , wherein an outer surface of the inner tube or an inner surface of the outer tube is coated with a low friction coating.
7. 7 . The tissue removal device of claim 1 , wherein the reciprocating arm is disposed between the inner tube and the worm gear.
8. 8 . The tissue removal device of claim 1 , wherein the first spur gear is distal to the worm.
9. 9 . The tissue removal device of claim 1 , wherein the worm is disposed between the worm gear and the second spur gear.
10. 10 . The tissue removal device of claim 1 , wherein the first and second spur gears are configured to rotate, and wherein the second spur gear is configured to rotate four times faster than the first spur gear.
11. 11 . The tissue removal device of claim 1 , wherein the worm and worm gear are configured to reciprocate the inner tube at about 2.8 cycles per second.
12. 12 . The tissue removal device of claim 1 , further comprising a power switch configured to activate or de-active the motor, wherein the motor is configured turn off when inner tube is in its distalmost potion relative to the housing by sensing a status of the power switch.
13. 13 . A tissue removal device, comprising: a drive shaft configured to be rotated by a motor; an outer tube having a first lumen, a closed distal end, and a window through a sidewall thereof leading to the first lumen, the window being located proximal of the closed distal end; an inner tube disposed within the first lumen and having a second lumen extending between an open distal end and an open proximal end, wherein the open proximal end is connected to a suction source, wherein the inner tube is operatively coupled to the drive shaft such that, when the drive shaft rotates, the inner tube rotates and reciprocates simultaneously within the outer tube; and a reciprocating mechanism coupled between the drive shaft and the inner tube that converts rotational movement of the drive shaft into reciprocating movement of the inner tube, wherein the reciprocating mechanism comprises a worm attached to the drive shaft and a worm gear attached to the inner tube via a crank.
14. 14 . The tissue removal device of claim 13 , further comprising a rotation mechanism coupled between the drive draft-shaft and the inner tube that transfers rotational movement of the drive shaft to the inner tube.
15. 15 . The tissue removal device of claim 14 , wherein the rotation mechanism comprises a first spur gear attached to the drive shaft and a second spur gear attached to the inner tube, wherein the first spur gear is meshed with the second spur gear.
16. 16 . The tissue removal device of claim 13 , wherein the crank has a first end attached to the worm gear at a non-centric location, and a second end attached to a collar attached to the inner tube.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a continuation of U.S. patent application Ser. No. 17/357,993, filed Jun. 25, 2021, which is a continuation of U.S. patent application Ser. No. 16/190,770, filed Nov. 14, 2018, now U.S. Pat. No. 11,045,217, which is a continuation of U.S. patent application Ser. No. 15/365,502, filed Nov. 30, 2016, now U.S. Pat. No. 10,130,389, which is a continuation of U.S. patent application Ser. No. 14/983,024, filed Dec. 29, 2015, now U.S. Pat. No. 9,539,019, which is a continuation of U.S. patent application Ser. No. 14/680,276, filed Apr. 7, 2015, now U.S. Pat. No. 9,339,288, which is a continuation of U.S. patent application Ser. No. 12/432,686, filed Apr. 29, 2009, now U.S. Pat. No. 9,095,366. BACKGROUND OF THE INVENTION The present invention relates generally to methods, systems and devices for the removal of tissue and relates more particularly to methods, systems, and devices well-suited for the removal of uterine fibroids and other abnormal gynecological tissues. It is believed that uterine fibroids occur in a substantial percentage of the female population, perhaps in at least 20 to 40 percent of all women. Uterine fibroids are well-defined, non-cancerous tumors that are commonly found in the smooth muscle layer of the uterus. In many instances, uterine fibroids can grow to be several centimeters in diameter and may cause symptoms like menorrhagia (prolonged or heavy menstrual bleeding), pelvic pressure or pain, and reproductive dysfunction. Current treatments for uterine fibroids include pharmacological therapy, hysterectomy, uterine artery embolization, and hysteroscopic resection. Pharmacological therapy typically involves the administration of NSAIDS (non-steroidal anti-inflammatory drugs), estrogen-progesterone combinations, and GnRH (gonadotropin releasing hormone) analogues. However, current pharmacological therapies are largely ineffective and merely palliative. By comparison, a hysterectomy involves the surgical removal of the uterus from a patient. For this reason, a hysterectomy represents a highly effective way of ridding a patient of uterine fibroids. As a result, several hundred thousand hysterectomies are typically performed annually in the United States to treat uterine fibroids. However, despite their widespread use, hysterectomies also possess certain disadvantages, such as a loss of fertility, sexual dysfunction, and the risks commonly associated with a major surgical procedure, such as hemorrhaging, lesions, infections, pain and prolonged recovery. Uterine artery embolization involves inserting a catheter into a femoral artery and then guiding the catheter to a uterine fibroid artery. Small particles are then injected from the catheter into the fibroid artery, blocking its blood supply and causing it to eventually shrink and die. Although this procedure is less invasive than a hysterectomy, it often results in pain-related, post-surgical complications. Moreover, the physicians that are trained to perform uterine artery embolization are typically interventional radiologists, as opposed to physicians trained specifically to take care of gynecological problems, whereas the physicians trained specifically to take care of gynecological problems typically do not possess the skill to perform catheter-based uterine artery embolization. Hysteroscopic resection typically involves inserting a hysteroscope (i.e., an imaging scope) into the uterus through the vagina, i.e., transcervically, and then cutting away the fibroid from the uterus using a device delivered to the fibroid by the hysteroscope. Hysteroscopic resections typically fall into one of two varieties. In one variety, an electrocautery device in the form of a loop-shaped cutting wire is fixedly mounted on the distal end of the hysteroscope—the combination of the hysteroscope and the electrocautery device typically referred to as a resectoscope. The transmission of electrical current to the uterus with a resectoscope is typically monopolar, and the circuit is completed by a conductive path to the power unit for the device through a conductive pad applied to the patient's skin. In this manner, tissue is removed by contacting the loop with the part of the uterus wall of interest. Examples of such devices are disclosed, for example, in U.S. Pat. No. 5,906,615, inventor Thompson, issued May 25, 1999. In the other variety of hysteroscopic resection, an electromechanical cutter is inserted through a working channel in the hysteroscope. Tissue is then removed by contacting the cutter, which typically has a rotating cutting instrument, with the part of the uterus wall of interest. Examples of the electromechanical cutter variety of hysteroscopic resection are disclosed in, for example, U.S. Pat. No. 7,226,459, inventors Cesarini et al., issued Jun. 5, 2007; U.S. Pat. No. 6,032,673, inventors Savage et al., issued Mar. 7, 2000; U.S. Pat. No. 5,730,752, inventors Alden et al., issued Ma