Method and apparatus for sizing, stabilizing and/or reducing the circumference of an anatomical structure

Claim 2

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments and separating the plurality of substantially rigid suture support segments from each other.

Claim 3

The delivery system of claim 1, wherein the plurality of segment holders comprise linking structure to link the segment holders together.

Claim 4

The delivery system of claim 2, wherein the segment holders, when linked together, define consistent dimensions to precisely size an anatomical vascular structure.

Claim 5

The delivery system of claim 2, wherein the segment holders, when linked together, define consistent intervals for delivering the suture support segments to an anatomical vascular structure.

Claim 6

The delivery system of claim 2, wherein the linking structure is constructed to allow a desired number of segment holders to be linked together to fit a particular anatomical structure.

Claim 7

The delivery system of claim 2, wherein the linking structure comprises a plurality of universal joints connecting adjacent segment holders together.

Claim 8

The delivery system of claim 2, wherein the linking structure comprises a plurality of ball-and-socket joints connecting adjacent segment holders together.

Claim 9

The delivery system of claim 2, wherein the linking structure comprises a plurality of joints connecting adjacent segment holders together, the joints having sufficient friction to maintain linked-together segment holders in a desired overall shape but allowing relative movement between adjacent segment holders.

Claim 10

The delivery system of claim 1, wherein each segment holder readily releasably secures exactly one substantially rigid support segment.

Claim 11

The delivery system of claim 1, wherein each segment holder comprises at least one belt constructed to extend at least partially around a respective suture support segment to readily releasably secure the suture support segment to the segment holder.

Claim 12

The delivery system of claim 10, wherein each segment holder comprises opposite ends, further wherein the at least one belt of each segment holder is disposed at a predetermined location between the opposite ends to provide a visual reference point.

Claim 13

The delivery system of claim 10, wherein the at least one belt of each segment extends through at least one aperture of the suture support segment.

Claim 14

The delivery system of claim 10, wherein the at least one belt defines a separation notch, the belt being severable at the separation notch to separate the suture support segment from the segment holder.

Claim 15

The delivery system of claim 1, wherein each segment holder comprises a clamp fin, the clamp fin being constructed for ready grasping to allow easy relocation of the segment holder.

Claim 16

The delivery system of claim 1, further comprising a packaging material, the packaging material encasing each of the plurality of segment holders individually.

Claim 17

The delivery system of claim 1, further comprising a packaging material, the packaging material encasing the plurality of segment holders collectively.

Claim 18

The delivery system of claim 16, wherein the packaging material is substantially in the shape of the mitral or tricuspid orifice of a human heart.

Claim 19

A sizing system for measuring an anatomical structure during a surgical procedure, the sizing system comprising a plurality of discrete sizing elements, each sizing element being of a known substantially uniform length, the plurality of sizing elements including linking structure to link the sizing elements together, the linking structure having sufficient friction to maintain linked-together sizing elements in a desired overall shape but allowing relative movement between adjacent sizing elements to accommodate the particular shape of the anatomical structure, the sizing elements being constructed for placement generally along the anatomical structure to be measured.

Claim 20

A sizing system for measuring an anatomical structure during a surgical procedure, the sizing system comprising a plurality of discrete sizing elements, each sizing element being of a known substantially uniform length, the plurality of sizing elements including linking structure to link the sizing elements together, the linking structure having sufficient friction to maintain linked-together sizing elements in a desired overall shape but allowing relative movement between adjacent sizing elements to accommodate the particular shape of the anatomical structure, the sizing elements being constructed for placement generally along the anatomical structure to be measured.

Claim 21

The sizing system of claim 18, wherein the sizing elements are segment holders, the sizing system further comprising a plurality of substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of suture support segments to at least stabilize the anatomical structure along the line of suture support segments, the suture support segments being readily releasably secured to the segment holders.

Claim 22

The sizing system of claim 19, wherein the suture support segments have opposite ends, the sizing elements supporting facing ends of adjacent suture support segments about 3 mm apart.

Claim 23

The sizing system of claim 18, wherein the linking structure comprises a plurality of joints connecting adjacent sizing elements together, the joints being spaced about 1 cm apart.

Claim 24

The sizing system of claim 18, wherein the linking structure comprises a plurality of universal joints connecting adjacent sizing elements together.

Claim 25

The sizing system of claim 18, wherein each sizing element comprises a clamp fin, the clamp fin being constructed for ready grasping to allow easy relocation of the sizing element.

Claim 26

A sizing and delivery system for use in a surgical procedure on the heart of a patient, the sizing and delivery system comprising: segment means for reducing the circumference of a heart valve, the segment means comprising a plurality of substantially rigid, substantially identical suture support segments, the suture support segments having aperture means therethrough for receiving sutures, the segment means being constructed for placement at least partially circumferentially about the heart valve to form a line of discrete suture support segments for reducing the circumference of and stabilizing the heart valve along the line of discrete suture support segments; and segment holding means for releasably holding the segment means during delivery of the segment means to the heart during the surgical procedure, the segment holding means comprising a plurality of substantially identical segment holders that are readily releasably securable to the plurality of substantially rigid suture support segments, the segment holders each including linking means for connecting adjacent segment holders together; wherein: a desired number of segment holders can be linked together by linking structure to form a chain of linked segment holders of a desired length, corresponding to the size of the heart valve of the patient, the linking structure having sufficient friction to maintain the linked-together segment holders in a desired overall shape but allowing relative movement between adjacent segment holders to accommodate the particular shape of the heart valve of the patient; the segment holders are each discrete sizing elements of a known, substantially uniform length for precise valve sizing, the sizing elements being constructed for placement generally along the heart valve of the patient; and the segment holders maintain each suture support segment a known distance from an adjacent suture support segment, creating substantially uniform intervals for implantation of the suture support segments.

Claim 27

A sizing and delivery system for use in a surgical procedure on the heart of a patient, the sizing and delivery system comprising: segment means for reducing the circumference of a heart valve, the segment means comprising a plurality of substantially rigid, substantially identical suture support segments, the suture support segments having aperture means therethrough for receiving sutures, the segment means being constructed for placement at least partially circumferentially about the heart valve to form a line of discrete suture support segments for reducing the circumference of and stabilizing the heart valve along the line of discrete suture support segments; and segment holding means for releasably holding the segment means during delivery of the segment means to the heart during the surgical procedure, the segment holding means comprising a plurality of substantially identical segment holders that are readily releasably securable to the plurality of substantially rigid suture support segments, the segment holders each including linking means for connecting adjacent segment holders together; wherein: a desired number of segment holders can be linked together by linking structure to form a chain of linked segment holders of a desired length, corresponding to the size of the heart valve of the patient, the linking structure having sufficient friction to maintain the linked-together segment holders in a desired overall shape but allowing relative movement between adjacent segment holders to accommodate the particular shape of the heart valve of the patient; the segment holders are each discrete sizing elements of a known, substantially uniform length for precise valve sizing, the sizing elements being constructed for placement generally along the heart valve of the patient; and the segment holders maintain each suture support segment a known distance from an adjacent suture support segment, creating substantially uniform intervals for implantation of the suture support segments.

Claim 28

The sizing and delivery system of claim 24, wherein the segment holders are each about 1 cm long.

Claim 29

The sizing and delivery system of claim 24, wherein the segment holders maintain each suture support segment about 3 mm from an adjacent suture support segment, creating uniform intervals of about 3 mm for implantation of the suture support segments.

Claim 30

The sizing and delivery system of claim 24, further comprising belt means for readily releasably securing the segment means to the segment holding means.

Claim 31

The sizing and delivery system of claim 27, wherein the belt means comprises separation notch means for allowing the belt means to be readily severed to release the segment means from the segment holding means.

Claim 34

The method of claim 29, further comprising: (e) using the sizing system to maintain a plurality of discrete, substantially rigid suture support segments at consistent intervals; (f) suturing the suture support segments into fixed relationship with the anatomical structure at the consistent intervals maintained by the sizing system, the suture support segments being disposed in a line of suture support segments for at least stabilizing the anatomical structure along the line of suture support segments.

Claim 35

The method of claim 30, further comprising: (g) releasing the plurality of suture support segments from the plurality of sizing elements.

Claim 36

The method of claim 29, wherein step (a) includes placing the sizing system along the perimeter of an unfurled anterior leaflet of a mitral or tricuspid heart valve, and step (d) includes determining the perimeter of the unfurled anterior leaflet.

Claim 37

The method of claim 32, further comprising: (e) using the sizing system to maintain a plurality of discrete, substantially rigid suture support segments at consistent intervals; and (f) suturing the suture support segments into fixed relationship with a posterior mitral annulus or a posterior and anterior tricuspid annulus at the consistent intervals maintained by the sizing system to bring the circumference of the posterior mitral annulus or posterior and anterior tricuspid annulus into correlation with the perimeter of the unfurled anterior leaflet.

Claim 38

The method of claim 33, wherein step (f) includes leaving the anterior mitral annulus or the septal tricuspid annulus free of sutures.

Claim 39

The method of claim 32, wherein the method further includes enclosing the support segments within an autologous pericardium ring that is sutured onto the posterior mitral or posterior and anterior tricuspid annulus.

Claim 40

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, the plurality of segment holders comprising linking structure to link the segment holders together, the linking structure comprising a plurality of joints connecting adjacent segment holders together, the joints having sufficient friction to maintain linked-together segment holders in a desired overall shape but allowing relative movement between adjacent segment holders.

Claim 41

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, the plurality of segment holders comprising linking structure to link the segment holders together, the linking structure comprising a plurality of joints connecting adjacent segment holders together, the joints having sufficient friction to maintain linked-together segment holders in a desired overall shape but allowing relative movement between adjacent segment holders.

Claim 42

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, wherein each segment holder readily releasably secures exactly one substantially rigid support segment.

Claim 43

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, wherein each segment holder readily releasably secures exactly one substantially rigid support segment.

Claim 44

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, wherein each segment holder comprises a clamp fin, the clamp fin being constructed for ready grasping to allow easy relocation of the segment holder.

Claim 45

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, wherein each segment holder comprises a clamp fin, the clamp fin being constructed for ready grasping to allow easy relocation of the segment holder.

Claim 46

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders constructed to be released from the plurality of substantially rigid suture support segments once the suture support segments are delivered to the anatomical structure, the suture support segments being constructed to remain at the anatomical structure after delivery and the plurality of segment holders being constructed for complete removal from the anatomical structure after delivery.

Claim 47

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders constructed to be released from the plurality of substantially rigid suture support segments once the suture support segments are delivered to the anatomical structure, the suture support segments being constructed to remain at the anatomical structure after delivery and the plurality of segment holders being constructed for complete removal from the anatomical structure after delivery.

Claim 48

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for directly supporting sutures extending into the anatomical structure and for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, the plurality of segment holders being distinct from the sutures.

Claim 49

A delivery system for delivering a plurality of substantially rigid suture support segments during a surgical procedure, the substantially rigid suture support segments to be placed at least partially circumferentially about an anatomical structure to form a line of discrete suture support segments for directly supporting sutures extending into the anatomical structure and for at least stabilizing the anatomical structure along the line of discrete suture support segments, the delivery system comprising a plurality of segment holders, the plurality of segment holders being readily releasably securable to the plurality of substantially rigid suture support segments, the plurality of segment holders being distinct from the sutures.