Uterine fibroid tissue removal device

• US 10,130,389 B2
• Filed: 11/30/2016
• Issued: 11/20/2018
• Est. Priority Date: 04/06/2007
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: Sullivan, Roy Hewitt, Chin, Albert Chun-Chi, Litscher, Eric Karl, Churchill, William Lucas, Adams, Ronald David, Gruber, William Harwick, Jacobs, David
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): SIMPSON, SARAH A
• Application Number:
  US15/365,502
• Publication Number:
  US 20170079684A1
• Time in Patent Office: 720 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/3205 Excision instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00424 ergonomic, e.g. fitting in fist
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/0073 with means for minimising or preventing pain during treatment
• CPC Class Codes: A61B 2017/22078 for rotating the instrument within a channel, e.g. an optical fibre
• CPC Class Codes: A61B 2017/22079 : with suction of debris
• CPC Class Codes: A61B 2017/2905 : flexible
• CPC Class Codes: A61B 2017/320004 : abrasive
• CPC Class Codes: A61B 2017/320024 : Morcellators, e.g. having a hollow cutting tube with an annular cutter for morcellating and removing tissue
• CPC Class Codes: A61B 2017/320028 : with reciprocating movements
• CPC Class Codes: A61B 2017/320064 : with tissue or sample retaining means
• CPC Class Codes: A61B 2017/320775 : Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2017/3466 : for simultaneous sealing of multiple instruments
• CPC Class Codes: A61B 2017/347 : Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2017/4216 : Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61M 1/842 : rotating continuously rotating surgical cutting instruments A61B17/32002

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.

Claims

1. A uterine fibroid tissue removal device, comprising:

a housing;

an outer tube having a distal end and a proximal end, the proximal end of the outer tube supported by the housing, the outer tube configured for transcervical insertion into a uterus and having a tissue resection window located proximate to the distal end of the outer tube, the tissue resection window having a longitudinally oriented length;

an inner tube disposed within the outer tube and configured to be translated and rotated relative to the outer tube during operation of the tissue removal device, the inner tube having an axial lumen; and

a unitary distal tip member formed separately from the inner tube, wherein the inner tube is formed from a first material and the distal tip member is formed from a second material harder than the first material, the distal tip member being attached to a distal end of the inner tube such that an axial lumen of the distal tip member is in fluid communication with the axial lumen of the inner tube, and such that the distal tip member translates and rotates relative to the outer tube along with the inner tube during operation of the tissue removal device so that a distal facing open cutting end of the distal tip member in fluid communication with the axial lumen of the distal tip member translates across the tissue resection window of the outer tube to sever tissue extending therethrough,

wherein the axial lumen of the distal tip member is smaller in cross-sectional area than the axial lumen of the inner tube.

2. The tissue removal device of claim 1, wherein the distal facing open cutting end of the distal tip member comprises an external bevel.

3. The tissue removal device of claim 2, wherein the external bevel comprises an angle of about 20 degrees.

4. The tissue removal device of claim 1, the second material comprising a hardness that exceeds the hardness of the first material by a Rockwell C hardness of at least about 10.

5. The tissue removal device of claim 1, wherein an outer diameter of the distal tip member is greater than an outer diameter of the inner tube, such that an outer surface of the distal tip member acts as a bearing surface against an inner surface of the outer tube during operation of the tissue removal device.

6. 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.

7. The tissue removal device of claim 1, further comprising:

an introducer device comprising an elongate sheath having an outer diameter of about 5.5 mm or less and comprising a first longitudinal lumen extending there through, at least a portion of the elongate sheath being configured to enter a patient'"'"'s uterus through the patient'"'"'s cervix;

wherein the outer tube has an outer diameter of less than about 5.5 mm and is configured to be received within the first longitudinal lumen.

8. The tissue removal device of claim 1, further comprising:

an introducer device comprising an elongate sheath having an outer diameter and comprising a first longitudinal lumen extending there through, at least a portion of the elongate sheath being configured to enter a patient'"'"'s uterus through the patient'"'"'s cervix;

wherein the outer tube has an outer diameter and is configured to be received within the first longitudinal lumen, and wherein a ratio of the outer diameter of the elongate sheath to the outer diameter of the outer tube is less than about 2.1.

9. A uterine fibroid tissue removal device, comprising:

a housing;

an outer tube having a distal end and a proximal end, the proximal end of the outer tube supported by the housing, the outer tube configured for transcervical insertion into a uterus and having a tissue resection window located proximate to the distal end of the outer tube, the tissue resection window having a longitudinally oriented length;

an inner tube disposed within the outer tube and configured to be translated and rotated relative to the outer tube during operation of the tissue removal device, the inner tube having an axial lumen; and

a unitary distal tip member formed separately from the inner tube, wherein the inner tube is formed from a first material and the distal tip member is formed from a second material harder than the first material, the distal tip member being attached to a distal end of the inner tube such that an axial lumen of the distal tip member is in fluid communication with the axial lumen of the inner tube, and such that the distal tip member translates and rotates relative to the outer tube along with the inner tube during operation of the tissue removal device so that a distal facing open cutting end of the distal tip member in fluid communication with the axial lumen of the distal tip member translates across the tissue resection window of the outer tube to sever tissue extending therethrough,

wherein the distal tip member has a length greater than a length of the tissue resection window.

10. The tissue removal device of claim 9, wherein the distal facing open cutting end of the distal tip member comprises an external bevel.

11. The tissue removal device of claim 10, wherein the external bevel comprises an angle of about 20 degrees.

12. The tissue removal device of claim 9, the second material comprising a hardness that exceeds the hardness of the first material by a Rockwell C hardness of at least about 10.

13. The tissue removal device of claim 9, wherein the inner tube is sufficiently flexible to bend in conformity with a bend in the outer tube while rotating within the outer tube.

14. The tissue removal device of claim 9, further comprising:

an introducer device comprising an elongate sheath having an outer diameter of about 5.5 mm or less and comprising a first longitudinal lumen extending there through, at least a portion of the elongate sheath being configured to enter a patient'"'"'s uterus through the patient'"'"'s cervix;

wherein the outer tube has an outer diameter of less than about 5.5 mm and is configured to be received within the first longitudinal lumen.

15. The tissue removal device of claim 9, further comprising:

an introducer device comprising an elongate sheath having an outer diameter and comprising a first longitudinal lumen extending there through, at least a portion of the elongate sheath being configured to enter a patient'"'"'s uterus through the patient'"'"'s cervix;

wherein the outer tube has an outer diameter and is configured to be received within the first longitudinal lumen, and wherein a ratio of the outer diameter of the elongate sheath to the outer diameter of the outer tube is less than about 2.1.