Tissue cutter with differential hardness

• US 9,095,366 B2
• Filed: 04/29/2009
• Issued: 08/04/2015
• 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): Nguyen, Victor
• Assistant Examiner(s): Simpson, Sarah
• Application Number:
  US12/432,686
• Publication Number:
  US 20090270896A1
• Time in Patent Office: 2,288 Days
• Field of Search: 606/169, 606/170, 606/171, 606/177, 606/178, 606 79- 85, 606/159, 606/166, 606/167, 604/22, 600/564, 600/565, 600/567
• US Class Current: 1/1
• 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
• 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 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

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

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 side opening proximate the distal end of the outer tube;

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

a unitary distal tip member formed separately from the inner tube out of 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 inner tube axial lumen, 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, wherein a distal facing open cutting end of the distal tip member in fluid communication with the lumen of the distal tip member translates across the side opening 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, and

wherein the distal facing open cutting end of the distal tip member comprises an external bevel.

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

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.

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

4. The tissue removal device of claim 2, wherein the second material comprises a hardness that exceeds the hardness of the first material by a Rockwell C hardness of at least about 20.

5. The tissue removal device 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.

6. The tissue removal device of claim 5, 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 therethrough, 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.

7. The tissue removal device of claim 1, wherein the external bevel comprises an angle of about 20 degrees.