Uterine fibroid tissue removal device
View Patent ↗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.
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.