Tissue separation device and methods for using same
A device for separating a sample of tissue in a controlled and precise manner and, more particularly, to produce a piece of tissue having a generally planar configuration and, optionally, additional desired characteristics, such as a predetermined maximum thickness, and selected tissue type. The device is adjustable to allow for different thicknesses and different operational speeds for application to different types of recovered tissue samples.
1. A device for producing a tissue product from a tissue sample,
wherein the tissue product comprises a piece of tissue having a generally planar configuration and a predetermined maximum thickness between first and second surfaces thereof, the device comprising:
(A) a support base ( 16 ) for supporting the device on a horizontal surface;
(B) a drum assembly ( 12 ) mounted on the support base ( 16 ) and comprising:
a rotatable cylindrical drum ( 20 ) having a longitudinal axis (LA) oriented parallel to the horizontal surface and an exterior cylindrical surface ( 32 ),
a shaft ( 42 ) extending through the drum ( 20 ) coincident with the longitudinal axis (LA), and
a hand wheel mounted to the drum ( 20 ) capable of manually rotating the drum ( 20 );
(C) a drum motor assembly ( 22 ) mounted to the support base ( 16 ) and operably engaged with the shaft ( 42 ) of the drum assembly ( 12 ) and capable of continuously rotating the drum ( 20 ) about the longitudinal axis (LA);
(D) a blade assembly ( 14 ) comprising a blade ( 64 ) which is longitudinally aligned with and proximate to the exterior surface ( 32 ) of the drum ( 20 ) and capable of cutting a tissue sample mounted on the exterior surface ( 32 ) to form the tissue product;
(E) a lateral movement mechanism ( 30 ) operably engaged with and carrying the blade assembly ( 14 ) and capable of moving the blade assembly ( 14 ) reciprocatingly in a lateral direction (LM);
(F) a lateral drive assembly ( 28 ) operably engaged with and capable of operating the lateral movement mechanism ( 30 ) to move the blade assembly ( 14 ) reciprocatingly in a lateral direction (LM), wherein the lateral movement mechanism ( 30 ), the lateral drive assembly ( 28 ), and the blade assembly ( 14 ) are, together, capable of continuously cutting a tissue sample mounted on the exterior surface ( 32 ) of the drum ( 20 ) by reciprocatingly moving the blade assembly ( 14 ) and blade ( 64 ) thereof in the lateral direction (LM);
(G) a blade motor assembly ( 26 ) mounted to the support base ( 16 ) and operably engaged with and capable of actuating the lateral drive assembly ( 28 ) to operate the lateral movement mechanism ( 30 ); and
(H) a thickness adjustment mechanism ( 24 ) which is partially mounted on the support base ( 16 ) and partially mounted to the lateral movement mechanism ( 30 ), thereby being operably engaged with the blade assembly ( 14 ), wherein the thickness adjustment mechanism ( 24 ) is capable of setting the maximum predetermined thickness of the tissue product by moving the blade assembly ( 14 ) in a linear direction (TA), which is perpendicular to the longitudinal axis (LA) of the drum ( 20 ), and positioning the blade ( 64 ) a distance (d) from the exterior surface ( 32 ) of the drum ( 20 ), wherein the distance (d) is equal to the maximum predetermined thickness of the tissue product, wherein the thickness adjustment mechanism ( 24 ) comprises:
a block ( 94 ) having a threaded bore ( 95 ) and being mounted to the lateral movement mechanism ( 30 ) which slidingly rests on two or more guide rails ( 76 a , 76 b ) which enable movement of the lateral movement mechanism ( 30 ) and the blade assembly ( 14 ) carried thereon in the linear direction (TA);
a bearing block ( 96 ) and adjacent seal plate ( 97 ) which are fixedly mounted to the support base ( 16 ) and have aligned threaded bores therethrough which are also aligned with the threaded bore ( 95 ) of the block ( 94 ); and
a threaded shaft ( 102 ) having a knob ( 103 ) at one end thereof, wherein the threaded shaft ( 102 ) is threadedly received through and engaged with the threaded bores of each of the block ( 94 ), the bearing block 196 ) and the seal plate ( 97 ), and
wherein the thickness adjustment mechanism ( 24 ) is manually operable by turning the knob ( 103 ) which moves the lateral movement mechanism ( 30 ) and the blade assembly ( 14 ) carried thereon in the linear direction (TA) and positions the blade ( 64 ) a distance (d) from the exterior surface ( 32 ) of the drum ( 20 ).
2. The device of claim 1 , further comprising one or more thickness setting plates ( 104 ) for setting the distance (d) between the blade ( 64 ) of the blade assembly ( 14 ) and the exterior surface ( 32 ) of the drum ( 20 ), wherein each of the one or more thickness setting plates ( 104 ) has a different respective thickness (t) and, when a selected one of the thickness setting plates ( 104 ) is positioned between the knob ( 103 ) and the seal plate ( 97 ), and the knob ( 103 ), the selected one of the thickness setting plates ( 104 ), and the seal plate ( 97 ) are in contact with one another, the distance (d) between the blade ( 64 ) of the blade assembly ( 14 ) and the exterior surface ( 32 ) of the drum ( 20 ) is equal to the respective thickness (t) of the selected one of the setting plates ( 104 ).
3. A method for producing a tissue product from a tissue sample using the device of claim 2 , wherein the tissue product comprises a piece of tissue having a generally planar configuration and a predetermined maximum thickness between first and second surfaces thereof, the method comprising the sequential steps of:
(1) optionally, modifying the tissue sample to have a size and shape suitable for use with the device
(2) mounting the tissue sample on the exterior surface ( 32 ) of the drum ( 20 );
(3) selecting and setting the maximum predetermined thickness of the tissue product, using the thickness adjustment mechanism ( 24 ) and a selected one of the one or more thickness setting plates ( 104 ), by selecting one of the one or more thickness setting plates ( 104 ), positioning the selected one thickness setting plate ( 104 ) between the knob ( 103 ) and the seal plate ( 97 ), turning the knob ( 103 ), until the knob ( 103 ), the selected one thickness setting plate ( 104 ), and the seal plate ( 97 ) are in contact with one another, thereby positioning the blade ( 64 ) of the blade assembly ( 14 ) a distance (d) from the exterior surface ( 32 ) of the drum ( 20 ), whereby the distance (d) between the blade ( 64 ) and the exterior surface ( 32 ) of the drum ( 20 ) is equal to the respective thickness (t) of the selected one thickness setting plate ( 104 );
(4) positioning the tissue sample in a suitable position relative to the blade ( 64 ) of the blade assembly ( 14 ) by manually rotating the drum ( 20 ) using the hand wheel, wherein the suitable position is when a leading edge of the tissue sample is proximate to but not yet in contact with the blade ( 64 );
(5) commencing lateral reciprocating movement of the blade assembly ( 14 ) by supplying power to the blade motor assembly ( 26 ), which actuates the lateral drive assembly ( 28 ), which operates the lateral movement mechanism ( 30 ), which moves the blade assembly ( 14 ) reciprocatingly in the lateral direction (LM);
(6) commencing rotation of the drum ( 20 ) and the tissue sample mounted on the exterior surface ( 32 ) thereof by supplying power to the drum motor assembly ( 22 );
(7) allowing the concurrent reciprocating movement of the blade assembly ( 14 ) and rotation of the drum ( 20 ) and the tissue sample mounted on the exterior surface ( 32 ) thereof to continue until all of the tissue sample has passed by the blade assembly ( 14 ) to form a first tissue product which remains on the drum and a second piece of tissue which has been separated from the first tissue product;
(8) optionally, removing the first tissue product from the drum ( 20 ), wherein the first tissue product has a generally planar configuration, a predetermined maximum thickness, and, optionally, consists essentially of a selected tissue type;
(9) optionally, removing the first tissue product from the drum ( 20 ) and mounting the second piece of tissue to the exterior surface ( 32 ) of the drum ( 20 ) as a next tissue sample to be cut, and repeating steps (3) to (7); and
(10) optionally, leaving the first tissue product on the drum ( 20 ) and using the first tissue product as a next tissue sample to be cut, and repeating steps (4) to (7).
4. The device of claim 1 , wherein the thickness adjustment mechanism ( 24 ) further comprises at least one locking knob which is capable of locking the thickness adjustment mechanism ( 24 ) in place after positioning the blade ( 64 ) a desired distance (d) from the exterior surface ( 32 ) of the drum ( 20 ) by turning the knob ( 103 ) and moving the lateral movement mechanism ( 30 ) and the blade assembly ( 14 ) carried thereon.
5. The device of claim 1 , wherein the rotatable cylindrical drum ( 20 ) has an adjustable rotational speed.
6. The device of claim 1 , wherein the drum assembly ( 12 ) further comprises a tissue clamp ( 58 ) for holding the tissue sample in place on the exterior surface ( 32 ) of the drum ( 20 ), and the drum ( 20 ) further comprises a longitudinally oriented groove which is sized and shaped to receive the tissue clamp ( 58 ) and a portion of the tissue sample therein.
7. The device of claim 1 , wherein the drum assembly ( 12 ) further comprises at least one upright bracket ( 52 ) mounted to the support base ( 16 ) and having an opening ( 54 ) for rotatably receiving an end ( 48 ) of the shaft ( 42 ) therein, thereby rotatably supporting the drum ( 20 ) above the support base ( 16 ).
8. The device of claim 1 , further comprising a housing ( 18 ) which is sized and shaped to cover and conceal one or more of: (C) the drum motor assembly ( 22 ), and (G) the blade motor assembly ( 26 ).
9. A device for producing a tissue product from a tissue sample, wherein the tissue product comprises a piece of tissue having a generally planar configuration and a predetermined maximum thickness between first and second surfaces thereof, the device comprising:
(A) a support base ( 16 ) for supporting the device on a horizontal surface;
(B) a drum assembly ( 12 ) mounted on the support base ( 16 ) and comprising:
a rotatable cylindrical drum ( 20 ) having a longitudinal axis (LA) oriented parallel to the horizontal surface and an exterior cylindrical surface ( 32 ),
a shaft ( 42 ) extending through the drum ( 20 ) coincident with the longitudinal axis (LA), and
a hand wheel mounted to the drum ( 20 ) capable of manually rotating the drum ( 20 );
(C) a drum motor assembly ( 22 ) mounted to the support base ( 16 ) and operably engaged with the shaft ( 42 ) of the drum assembly ( 12 ) and capable of continuously rotating the drum ( 20 ) about the longitudinal axis (LA);
(D) a blade assembly ( 14 ) comprising a blade ( 64 ) which is longitudinally aligned with and proximate to the exterior surface ( 32 ) of the drum ( 20 ) and capable of cutting a tissue sample mounted on the exterior surface ( 32 ) to form the tissue product;
(E) a lateral movement mechanism ( 30 ) operably engaged with and carrying the blade assembly ( 14 ) and capable of moving the blade assembly ( 14 ) reciprocatingly in a lateral direction (LM);
(F) a lateral drive assembly ( 28 ) operably engaged with and capable of operating the lateral movement mechanism ( 30 ) to move the blade assembly ( 14 ) reciprocatingly in a lateral direction (LM), wherein the lateral movement mechanism ( 30 ), the lateral drive assembly ( 28 ), and the blade assembly ( 14 ) are, together, capable of continuously cutting a tissue sample mounted on the exterior surface ( 32 ) of the drum ( 20 ) by reciprocatingly moving the blade assembly ( 14 ) and blade ( 64 ) thereof in the lateral direction (LM);
(G) a blade motor assembly ( 26 ) mounted to the support base ( 16 ) and operably engaged with and capable of actuating the lateral drive assembly ( 28 ) to operate the lateral movement mechanism ( 30 );
(H) a thickness adjustment mechanism ( 24 ) which is partially mounted on the support base ( 16 ) and partially mounted to the lateral movement mechanism ( 30 ), thereby being operably engaged with the blade assembly ( 14 ), wherein the thickness adjustment mechanism ( 24 ) is capable of setting the maximum predetermined thickness of the tissue product by moving the blade assembly ( 14 ) in a linear direction (TA), which is perpendicular to the longitudinal axis (LA) of the drum ( 20 ), and positioning the blade ( 64 ) a distance (d) from the exterior surface ( 32 ) of the drum ( 20 ), wherein the distance (d) is equal to the maximum predetermined thickness of the tissue product; and
(I) a tissue pusher assembly ( 15 ) comprising a tissue pusher ( 66 ) slidably mounted to the support base ( 16 ) and which is longitudinally aligned with and proximate to the exterior surface ( 32 ) of the drum ( 20 ), moveable in the same linear direction (TA) as, and independently of, the thickness adjustment mechanism ( 24 ), and capable of pressing and holding a tissue sample on the exterior surface ( 32 ) during operation of the device.
10. The device of claim 9 , wherein the (I) tissue pusher assembly ( 15 ) further comprises
at least one post ( 71 a , 71 b ) mounted to the support base ( 16 );
a plate ( 70 b ) mounted to the at least one post ( 71 a , 71 b ) at a fixed elevation above the support base ( 16 ) and having at least two threaded holes;
a slotted extension ( 100 ) which extends from a side of the tissue pusher ( 66 ) opposite the drum ( 20 ) and has two or more slots ( 101 ), each of which is sized and shaped to align with a corresponding one of the at least two threaded holes of the plate ( 70 b ); and
two or more knobs ( 106 a , 106 b ) each having a threaded shaft sized and shaped to be threadedly received, through a respective one of the two or more slots ( 101 ), and in a respective one of the at least two threaded holes of the plate ( 70 b ),
whereby the tissue pusher ( 66 ) and slotted extension ( 100 ) are slidably movable together, in the same linear direction (TA) as, but independently of, the thickness adjustment mechanism ( 24 ), and secured in a fixed position by turning the two or more knobs ( 106 a , 106 b ) until tight.
11. A device for producing a tissue product from a tissue sample, wherein the tissue product comprises a piece of tissue having a generally planar configuration and a predetermined maximum thickness between first and second surfaces thereof, the device comprising:
(A) a support base ( 16 ) for supporting the device on a horizontal surface;
(B) a drum assembly ( 12 ) mounted on the support base ( 16 ) and comprising:
a rotatable cylindrical drum ( 20 ) having a longitudinal axis (LA) oriented parallel to the horizontal surface and an exterior cylindrical surface ( 32 ),
a shaft ( 42 ) extending through the drum ( 20 ) coincident with the longitudinal axis (LA), and
a hand wheel mounted to the drum ( 20 ) capable of manually rotating the drum ( 20 );
(C) a drum motor assembly ( 22 ) mounted to the support base ( 16 ) and operably engaged with the shaft ( 42 ) of the drum assembly ( 12 ) and capable of continuously rotating the drum ( 20 ) about the longitudinal axis (LA);
(D) a blade assembly ( 14 ) comprising a blade ( 64 ) which is longitudinally aligned with and proximate to the exterior surface ( 32 ) of the drum ( 20 ) and capable of cutting a tissue sample mounted on the exterior surface ( 32 ) to form the tissue product, the blade assembly ( 14 ) further comprising:
a holder ( 90 ) and a clamp ( 92 ) which securely hold the blade ( 64 ) therebetween; and
at least two shafts ( 98 a , 98 b ) which are each affixed to (E) a lateral movement mechanism ( 30 ) and to either or both of the holder ( 90 ) and clamp ( 92 ), and which support the holder ( 90 ), blade ( 64 ) and clamp ( 92 ), which are assembled together, in an elevated position above the support base ( 16 ) and proximate to the exterior surface ( 32 ) of the drum ( 20 );
(E) the lateral movement mechanism ( 30 ) operably engaged with and carrying the blade assembly ( 14 ) and capable of moving the blade assembly ( 14 ) reciprocatingly in a lateral direction (LM);
(F) a lateral drive assembly ( 28 ) operably engaged with and capable of operating the lateral movement mechanism ( 30 ) to move the blade assembly ( 14 ) reciprocatingly in a lateral direction (LM), wherein the lateral movement mechanism ( 30 ), the lateral drive assembly ( 28 ), and the blade assembly ( 14 ) are, together, capable of continuously cutting a tissue sample mounted on the exterior surface ( 32 ) of the drum ( 20 ) by reciprocatingly moving the blade assembly ( 14 ) and blade ( 64 ) thereof in the lateral direction (LM);
(G) a blade motor assembly ( 26 ) mounted to the support base ( 16 ) and operably engaged with and capable of actuating the lateral drive assembly ( 28 ) to operate the lateral movement mechanism ( 30 ); and
(H) a thickness adjustment mechanism ( 24 ) which is partially mounted on the support base ( 16 ) and partially mounted to the lateral movement mechanism ( 30 ), thereby being operably engaged with the blade assembly ( 14 ), wherein the thickness adjustment mechanism ( 24 ) is capable of setting the maximum predetermined thickness of the tissue product by moving the blade assembly ( 14 ) in a linear direction (TA), which is perpendicular to the longitudinal axis (LA) of the drum ( 20 ), and positioning the blade ( 64 ) a distance (d) from the exterior surface ( 32 ) of the drum ( 20 ), wherein the distance (d) is equal to the maximum predetermined thickness of the tissue product.
12. A method for producing a tissue product from a tissue sample, wherein the tissue product comprises a piece of tissue having a generally planar configuration and a predetermined maximum thickness between first and second surfaces thereof, and wherein the method is performed using a device which comprises:
(A) a support base ( 16 ) for supporting the device on a horizontal surface;
(B) a drum assembly ( 12 ) mounted on the support base ( 16 ) and comprising:
a rotatable cylindrical drum ( 20 ) having a longitudinal axis (LA) oriented parallel to the horizontal surface and an exterior cylindrical surface ( 32 ),
a shaft ( 42 ) extending through the drum ( 20 ) coincident with the longitudinal axis (LA), and
a hand wheel mounted to the drum ( 20 ) capable of manually rotating the drum ( 20 );
(C) a drum motor assembly ( 22 ) mounted to the support base ( 16 ) and operably engaged with the shaft ( 42 ) of the drum assembly ( 12 ) and capable of continuously rotating the drum ( 20 ) about the longitudinal axis (LA);
(D) a blade assembly ( 14 ) comprising a blade ( 64 ) which is longitudinally aligned with and proximate to the exterior surface ( 32 ) of the drum ( 20 ) and capable of cutting a tissue sample mounted on the exterior surface ( 32 ) to form the tissue product;
(E) a lateral movement mechanism ( 30 ) operably engaged with and carrying the blade assembly ( 14 ) and capable of moving the blade assembly ( 14 ) reciprocatingly in a lateral direction (LM);
(F) a lateral drive assembly ( 28 ) operably engaged with and capable of operating the lateral movement mechanism ( 30 ) to move the blade assembly ( 14 ) reciprocatingly in a lateral direction (LM), wherein the lateral movement mechanism ( 30 ), the lateral drive assembly ( 28 ), and the blade assembly ( 14 ) are, together, capable of continuously cutting a tissue sample mounted on the exterior surface ( 32 ) of the drum ( 20 ) by reciprocatingly moving the blade assembly ( 14 ) and blade ( 64 ) thereof in the lateral direction (LM);
(G) a blade motor assembly ( 26 ) mounted to the support base ( 16 ) and operably engaged with and capable of actuating the lateral drive assembly ( 28 ) to operate the lateral movement mechanism ( 30 );
(H) a thickness adjustment mechanism ( 24 ) which is partially mounted on the support base ( 16 ) and partially mounted to the lateral movement mechanism ( 30 ), thereby being operably engaged with the blade assembly ( 14 ), wherein the thickness adjustment mechanism ( 24 ) is capable of setting the maximum predetermined thickness of the tissue product by moving the blade assembly ( 14 ) in a linear direction (TA), which is perpendicular to the longitudinal axis (LA) of the drum ( 20 ), and positioning the blade ( 64 ) a distance (d) from the exterior surface ( 32 ) of the drum ( 20 ), wherein the distance (d) is equal to the maximum predetermined thickness of the tissue product, the method comprising the sequential steps of:
(1) optionally, modifying the tissue sample to have a size and shape suitable for use with the device;
(2) mounting the tissue sample on the exterior surface of the drum ( 20 );
(3) selecting and setting the maximum predetermined thickness of the tissue product by positioning the blade ( 64 ) of the blade assembly ( 14 ) a distance (d) from the exterior surface ( 32 ) of the drum ( 20 ), using the thickness adjustment mechanism ( 24 );
(4) positioning the tissue sample in a suitable position relative to the blade ( 64 ) of the blade assembly ( 14 ) by manually rotating the drum ( 20 ) using the hand wheel, wherein the suitable position is when a leading edge of the tissue sample is proximate to but not yet in contact with the blade ( 64 );
(5) commencing lateral reciprocating movement of the blade assembly ( 14 ) by supplying power to the blade motor assembly ( 26 ), which actuates the lateral drive assembly ( 28 ), which operates the lateral movement mechanism ( 30 ), which moves the blade assembly ( 14 ) reciprocatingly in the lateral direction (LM);
(6) commencing rotation of the drum ( 20 ) and the tissue sample mounted on the exterior surface ( 32 ) thereof by supplying power to the drum motor assembly ( 22 );
(7) allowing the concurrent reciprocating movement of the blade assembly ( 14 ) and rotation of the drum ( 20 ) and the tissue sample mounted on the exterior surface ( 32 ) thereof to continue until all of the tissue sample has passed by the blade assembly ( 14 ) to form a first tissue product which remains on the drum ( 20 ) and a second piece of tissue which has been separated from the first tissue product;
(8) optionally, removing the first tissue product from the drum ( 20 ), wherein the first tissue product has a generally planar configuration, a predetermined maximum thickness, and, optionally, consists essentially of a selected tissue type;
(9) optionally, removing the first tissue product from the drum ( 20 ) and mounting the second piece of tissue to the exterior surface ( 32 ) of the drum ( 20 ) as a next tissue sample to be cut, and repeating steps (3) to (7); and
(10) optionally, leaving the first tissue product on the drum ( 20 ) and using the first tissue product as a next tissue sample to be cut, and repeating steps (4) to (7).
13. The method of claim 12 , wherein the device further comprises (I) a tissue pusher assembly ( 15 ) comprising a tissue pusher ( 66 ) slidably mounted to the support base ( 16 ) and which is longitudinally aligned with and proximate to the exterior surface ( 32 ) of the drum ( 20 ), moveable in the same linear direction (TA) as, and independently of, the thickness adjustment mechanism ( 24 ), and capable of pressing and holding a tissue sample on the exterior surface ( 32 ) during operation of the device; and the method further comprises:
after the step of (2) mounting the tissue sample on the exterior surface ( 32 ) of the drum ( 20 ), and before the steps of (5) commencing lateral reciprocating movement of the blade assembly ( 14 ) and (6) commencing rotation of the drum ( 20 ) and the tissue sample mounted on the exterior surface ( 32 ) thereof, and
positioning the tissue pusher ( 66 ) at a desired position and distance from the tissue sample whereby the tissue pusher ( 66 ) presses and holds the tissue sample on the exterior surface ( 32 ) of the drum ( 20 ).
14. The method of claim 12 , wherein the tissue sample comprises dermal tissue.
15. A tissue product produced by the method of claim 12 , wherein the tissue product has a generally planar configuration and a predetermined maximum thickness.
16. The tissue product of claim 15 , wherein the tissue product comprises a selected tissue type.
17. The tissue product of claim 15 , wherein the tissue product consists essentially of a selected tissue type.
18. The tissue product of claim 15 , wherein the tissue sample comprises dermal tissue.
19. The tissue product of claim 18 , wherein the tissue sample comprises processed dermal tissue, and wherein the tissue product consists essentially of reticular dermis and, optionally, at least a portion of papillary dermis.