TISSUE GRAFT PREPARATION SYSTEM
20230372587 ยท 2023-11-23
Assignee
Inventors
- John Xerogeanes (Atlanta, GA, US)
- SAMUEL ROQUE (Naples, FL, US)
- Zachary INGWER (Naples, FL, US)
- Jacob JOLLY (Naples, FL, US)
- Justin BOYLE (Naples, FL, US)
Cpc classification
A01N1/0242
HUMAN NECESSITIES
A61L27/3604
HUMAN NECESSITIES
International classification
Abstract
A support system is disclosed to prepare harvested soft tissue for grafting. Methods of graft preparation are also disclosed.
Claims
1. A graft support system, comprising: at least one tissue receiver configured to retain a tissue; a suture receiver supported remotely from at least one surface and configured to support the at least one tissue receiver remote relative to the at least one surface such that material can be passed between the at least one surface and the tissue supported by the graft support system; and wherein the suture receiver is configured to enable a stitch to be formed in the tissue and the suture to be looped around the tissue while maintaining the suture under constant tension by receiving a portion of a suture under tension extending from the tissue held within the at least one tissue receiver, whereby the portion of the suture under tension remains under tension by force applied to the suture when the portion of the suture under tension is manipulated from a first side of the suture receiver to a second side of the suture receiver.
2. The graft support system of claim 1, wherein the suture receiver comprises a suture receiver base slidably receiving a suture receiver body whereby, in a first position, a suture receiving opening is open to receive a suture under tension from the first side of the suture receiver and, in a second position, a suture release opening is open to release a suture under tension from a second side of the suture receiver.
3. The graft support system of claim 2, wherein the suture receiver body comprises a base support member and first and second arms separated to form a suture receiving chamber.
4. The graft support system of claim 3, further comprising a first retainer on a distal end of the first arm and a second retainer on a distal end of the second arm.
5. The graft support system of claim 2, wherein the suture receiver base slidably retains the suture receiver body such that the movement of the suture receiver body is limited to movement along a single axis.
6. The graft support system of claim 2, further comprising a suture receiver body restraint configured to limit movement of the suture receiver body between the first and second positions, wherein the suture receiver body restraint comprises at least one member extending from the suture receiver body to limit movement of the suture receiver body between the first and second positions along an axis while maintaining support of a tissue receiver support base by the suture receiver body.
7. The graft support system of claim 1, wherein the at least one tissue receiver comprises at least one post configured to receive the tissue.
8. The graft support system of claim 1, wherein the at least one tissue receiver comprises at least one tissue clamp.
9. The graft support system of claim 8, wherein the at least one tissue clamp extends from a tissue receiver support base, which is in turn supported by the suture receiver, and wherein the at least one tissue clamp is configured to grasp the tissue.
10. The graft support system of claim 9, wherein the at least one tissue clamp is formed from first and second clamp arms, whereby the second clamp arm is pivotably coupled to the first clamp arm at the tissue receiver support base.
11. The graft support system of claim 10, further comprising a clamp arm retainer configured to releasably secure the second clamp arm in a fixed position relative to the first clamp arm.
12. The graft support system of claim 10, further comprising a suture card receiver slot in the second clamp arm enabling the second clamp arm to receive an implant card containing a suture which enables sutures to be stored in close proximity to the site of use in the tissue.
13. The graft support system of claim 1, further comprising a suture receiver support configured to support the suture receiver remote relative to the at least one surface.
14. The graft support system of claim 13, further comprising at least one releasable connection system configured to enable the suture receiver support to be releasably attachable to the at least one surface.
15. The graft support system of claim 1, further comprising a rotatable support structure configured to enable the at least one tissue receiver to be rotated along an axis generally aligned with the tissue supported by the graft support system.
16. A graft support system, comprising: at least one tissue receiver configured to retain a tissue; a suture receiver supported remotely from at least one surface and configured to support the at least one tissue receiver remote relative to the at least one surface such that material can be passed between the at least one surface and the tissue supported by the graft support system; wherein the suture receiver is configured to enable a stitch to be formed in the tissue and the suture to be looped around the tissue while maintaining the suture under constant tension by receiving a portion of a suture under tension extending from the tissue held within the at least one tissue receiver, whereby the portion of the suture under tension remains under tension by force applied to the suture when the portion of the suture under tension is manipulated from a first side of the suture receiver to a second side of the suture receiver; wherein the suture receiver comprises a suture receiver base slidably receiving a suture receiver body whereby, in a first position, a suture receiving opening is open to receive a suture under tension from the first side of the suture receiver and, in a second position, a suture release opening is open to release a suture under tension from a second side of the suture receiver; and wherein the at least one tissue receiver comprises at least one tissue clamp.
17. A method of preparing a graft, comprising: supporting a piece of tissue via a graft support system such that the piece of tissue is supported away from at least one surface; placing at least a portion of a tag end of a suture under tension such that the suture attached to the piece of tissue is under tension; and passing the tag end of the suture from a first side of the graft support system to a second side of the graft support system while retaining the suture and at least a portion of a tag end under tension such that the tag end of the suture is in position to create another stitch within the piece of tissue.
18. The method of preparing a graft of claim 17, wherein passing the tag end of the suture from a first side of the graft support system to a second side of the graft support system while retaining the suture and at least a portion of a tag end under tension comprises passing the tag end of the suture from a first side of the graft support system to a second side of the graft support system without a user having to relinquish grip of the tag end.
19. The method of preparing a graft of claim 17, wherein supporting a piece of tissue via a graft support system such that the piece of tissue is supported away from a surface comprises supporting a piece of tissue via a graft support system comprising a suture receiver supported remotely from the at least one surface and configured to support at least one tissue receiver remote relative to the at least one surface such that material can be passed between the at least one surface and the piece of tissue supported by the graft support system.
20. The method of preparing a graft of claim 19, wherein passing the tag end of the suture from a first side of the graft support system to a second side of the graft support system while retaining the suture and at least a portion of a tag end of the suture under tension comprises moving a portion of a tag end of the suture under tension on the first side of the graft support system into a suture receiving chamber of a suture receiver body of the suture receiver, moving a suture receiver body from a first position to a second position whereby a suture release opening is opened and a suture receiving opening is closed, and removing the tag end under tension from the suture release opening, thereby placing the tag end under tension on the second side of the graft support system.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE DRAWINGS
[0051] As shown in
[0052] In at least one embodiment, the suture receiver 24 may be configured to move a suture receiver base 44 between a first position 48, as shown in
[0053] The graft support system 10 may include a tissue receiver support base 18, as shown in
[0054] The suture receiver 24, as shown in
[0055] In at least one embodiment, the graft support system 10 may include a suture receiver support 22 configured to support the tissue receiver support base 18 and the suture receiver 24 remote from the surface 16. The suture receiver support 22 may be formed from one or more support members 38 configured to be removably attached to the surface 16. In at least one embodiment, the support member 38 may be, but is not limited to being, a shaft. The shaft may have a cylindrical cross-sectional shape or other shaped cross-section. The support member 38 may be configured to be removably attached to the surface 16. In at least one embodiment, the support member 38 may include one or more releasable connection systems 32 positioned distally of the suture receiver 24. In at least one embodiment, the releasable connection system 32 may be positioned on a distal end 40 of the support member 38 and may include one or more slots 42 configured to mate with protrusions 43, as shown in
[0056] The graft support system 10 may include a system base 34 configured to receive the support member 38 and to enable the support member 38 to extend from and to support a piece of tissue 12 in the tissue securement assembly 35 above the system base 34. The system base 34 may also include a second tissue securement assembly 36. The system base 34 may have any configuration enabling the first and second tissue securement assemblies 35, 36 to extend away from the system base 34 orthogonally, or nonorthogonally and nonparallel to the system base 34. The first and second tissue securement assemblies 35, 36 may be fixedly or movably attached to the system base 34. In at least one embodiment, the system base 34 may be configured to rest on top of a benchtop, tabletop or the like. In other embodiments, the system base 34 may be fixedly attached to a support structure such as, but not limited to a bench or a table. The suture receiver 24 may be supported above the system base 34 via the suture receiver support 22, such as, but not limited to, the one or more support members 38.
[0057] In another embodiment, as shown in
[0058] In at least one embodiment, as shown in
[0059] The suture receiver 24 may enable a suture 14 attached to the tissue 12 to remain under tension while being passed from one side 28 to another side 30 without having to pass the suture from one hand to another and possibly lose tension. In particular, the suture receiver 24 may be configured to enable a stitch to be formed in the tissue, and the suture 14 to be looped around the tissue while maintaining the suture 14 under constant tension by receiving a portion of a suture under tension 26 extending from the tissue 12 held within the tissue receiver 19. The portion of the suture under tension 26 remains under tension by force applied to the suture 14 by a user such that the portion of the suture 14 under tension is manipulated from a first side 28 of the tissue securement assembly 35 and suture receiver 24 to a second side 30 of the tissue securement assembly 35 and suture receiver 24.
[0060] In at least one embodiment, the suture receiver 24 may include a suture receiver base 44 configured to slidably receive a suture receiver body 46 whereby, in a first position 48, as shown in
[0061] In at least one embodiment, the suture receiver 24 may be formed from a suture receiver body 46 that is slidable relative to the suture receiver base 44. The suture receiver body 46 may include a base support member 56 and first and second arms 58, 60 separated to form a suture receiving chamber 62. The suture receiving chamber 62 may have any appropriate configuration enabling a suture to be received therein and moved from a first side 28 to a second side 30 of the tissue securement assembly 35 and suture receiver 24. In a first position 48, a suture receiving opening 50 is open on a first side 28 of the tissue securement assembly 35 and suture receiver 24. At the same time, the suture release opening 54 on the second side 30 is closed and the second arm 60, which is on the second side 30, is supporting the suture receiver 24. In the first position 48, the first side 28 of the suture receiver 24, in particular, the first arm 58, is unsupported. As such, a suture 14 is capable of being inserted into the suture receiving opening 50 on the first side 28 of the suture receiver 24 without obstruction. The suture receiving opening 50 receives a suture 14 under tension from the first side 28 of the suture receiver 24 via the suture receiving opening 50.
[0062] The suture receiver base 44 of the suture receiver 24 may be moved to a second position 52 in which the suture release opening 54 is open and the suture receiving opening 50 is closed. In this position, the suture receiver 24 is supported by the first side 28 of suture receiver 24 and releases a suture 14 under tension from the second side 30 of the suture receiver 24 via the suture release opening 54.
[0063] The suture receiver 24 may also include a retention mechanism 64 configured to releasably attach the suture receiver 24 to the suture receiver base 44. In at least one embodiment, the retention mechanism 64 may be, but is not limited to being a first retainer 66 on a distal end 68 of the first arm 58 and a second retainer 70 on a distal end 72 of the second arm 60. The first and second retainers 66, 70 may be aligned along a longitudinal axis 74 enabling the suture receiver body 46 to be attached to the suture receiver base 44 by sliding the first and second retainers 66, 70 into at least one receiver 76 in the suture receiver base 44. In at least one embodiment, the first and second retainers 66, 70 may be, but are not limited to being, cylindrical. The cross-sectional shape of the first and second retainers 66, 70 may be another appropriate configuration other than cylindrical still enabling the suture receiver body 46 to slide relative to the suture receiver base 44 when in use. The suture receiver base 44 may be configured to slidably retain the suture receiver body 46 such that the movement of the suture receiver body 46 is limited to movement along a single axis 73, which in at least one embodiment, is aligned, and, in at least one embodiment, is coaxial, with the longitudinal axis 74.
[0064] The graft support system 10 may also include a suture receiver body restraint 78 configured to limit movement of the suture receiver support 46 between the first and second positions 48, 52 while maintaining support of the tissue receiver support base 18 by the suture receiver support 22. In particular, the suture receiver body restraint 78 ensures that the suture receiver body 46 and tissue securement assembly 35 attached thereto is supported either by the first arm 58 or the second arm 60 and prevents the suture receiver body 46 and tissue securement assembly 35 from falling off the suture receiver base 44. In at least one embodiment, the suture receiver body restraint 78 may include one or more members extending from the suture receiver base 44 into the suture receiving chamber 62. The suture receiver body restraint 78 may be, but is not limited to being, a pin 80 positioned in the suture receiving chamber 62 and attached to the suture receiver base 44. As the suture receiver body 46 moves laterally, the suture receiver body 46 contacts the suture receiver body restraint 78 and movement stops.
[0065] In at least one embodiment, the suture receiver body restraint 78 may be a pin 80, as shown in
[0066] The graft support system 10 may also include one or more tissue receivers 19. In at least one embodiment, the tissue receiver 19 may be one or more posts 21, as shown in
[0067] The tissue receiver 19 is not limited to being a post 21 but may also be any other structure configured to retain a piece of material 12. In at least one embodiment, the tissue receiver 19 may be one or more tissue clamps 35 coupled to the tissue receiver support base 18 and configured to grasp a graft 12, as shown in
[0068] In at least one embodiment, the punch receiver 98 may be an orifice 100 in the first clamp arm 90 near the distal end 95 of the first clamp arm 90 and aligned with the graft punch 94 on the second clamp arm 92 such that at least a portion of the graft punch 94 extends into the orifice 100 in the first clamp arm 90 when in a closed position. In a closed positioned of at least one embodiment, the distal end 102 of the graft punch 94 may extend into and through the orifice 100 in the first clamp arm 90. The orifice 100 may have any appropriate size. In at least one embodiment, the orifice 100 may be sized to be slightly smaller than an outer diameter 104 of a base 106 of the graft punch 94. As such, the orifice 100 stops movement of the graft punch 94 when the base 106 of the graft punch 94 contacts the first clamp arm 90 forming the orifice 100. The orifice 100 may stop movement of the second clamp arm 92 from rotating towards the first clamp arm 90 when the second clamp arm 92 is generally parallel with the first clamp arm 90.
[0069] In other embodiments, the first and second clamp arms 90, 92 may be configured with distal ends having any configuration enabling the first and second clamp arms 90, 92 to grasp tissue. The first and second clamp arms 90, 92 may be configured identically, as shown in
[0070] The second clamp arm 92 may be biased to rotate away from the first spring arm 90. In at least one embodiment, a spring 108, such as, but not limited to, a torsion spring, as shown in
[0071] The graft support system 10 may also include a tissue receiver support base 18 configured to support one or more tissue clamps 35. The tissue receiver support base 18 may have any appropriate configuration capable of supporting a tissue clamp 35. In at least one embodiment, the tissue receiver support base 18 may be a generally planar member configured to enable a clamp 35 to be attached thereto. The first clamp arm 90 may extend from a distal end of the tissue receiver support base 18. The second clamp arm 90 may also be rotatably coupled to the tissue receiver support base 18. In at least one embodiment, as shown in
[0072] The graft support system 10 may also include a clamp arm retainer 114 configured to releasably secure the second clamp arm 92 in a fixed position relative to the first clamp arm 90. The clamp arm retainer 114 may include a retainer arm 16 pivotably coupled to the second clamp arm 92 at a pivot point 120. The retainer arm 16 may include an actuator end 118 configured to be actuated by a user by pivoting the actuator end 118 of the retainer arm 116 relative to the pivot point 120 where the retainer arm 116 is pivotably coupled to the second clamp arm 92.
[0073] The retainer arm 16 may include an engagement system 122 configured to releasably contact the first clamp arm 90 to retain the second clamp arm 92 in a desired position relative to the first clamp arm 90. As such, the graft support system 10 may be used to grab and hold a piece of tissue 12, such as, but not limited to, a graft, via the graft punch 94. In at least one embodiment, the engagement system 122 may include protrusion 124, such as a tooth 124 or other such protrusion, that may extend from a tissue receiver support base 18 and may be configured to be received in one or more grooves 128 on a surface 130 of the retainer arm 116 facing the tooth 124. In at least one embodiment, the one or more grooves 128 may be a plurality of grooves 128. The grooves 128 may extend into the surface 130 and may be formed with one more teeth extending from the surface and the like. Alternatively, a configuration resembling a gear rack 132 may be positioned on the surface 130 of the retainer arm 116 facing the tooth 124. The gear rack 132 may be attached to or may be formed integrally within the retainer arm 116.
[0074] The graft support system 10 may also include a retainer arm biasing system 134 configured to bias the retainer arm 116 into contact with a stop feature 138 in communication with the first clamp arm 90. The retainer arm biasing system 134 may be configured to bias the one or more grooves 128 on the surface 130 of the retainer arm 116 facing the tooth 124 towards the tooth 124 on the first clamp arm 90. As such, the second clamp arm 92 is prevented from moving unless a user pulls the actuator end 118 of the retainer arm 116 against the biasing force, which in at least one embodiment is towards a thumb pad 135 on the second clamp arm 92. In such configuration, the second clamp arm 92 remains temporarily fixed in position at all times with the retainer arm 116 biased against the tooth 124 until a user disengages the retainer arm 116 by pressing the actuator end 118 towards the thumb pad 136.
[0075] The graft support system 10 may also include a stop 138 configured to limit movement of the second clamp arm 92 relative to the first clamp arm 90 so the second clamp arm 92 doesn't open too wide. In at least one embodiment, the stop 138 may extend from the retainer arm 116 towards the first clamp arm 90 such that the stop 138 may contact the first clamp arm 90, the tissue receiver support base 18 or another component when the second clamp arm 92 is rotated away from the first clamp arm 90, thereby limiting movement of second clamp arm 92. The stop 138 may be any member of sufficient size and strength to limit movement of the second clamp arm 92, such as, but not limited to, by contacting the first clamp arm 90 or the tissue receiver support base 18.
[0076] The graft support system 10 may also include a suture card receiver slot 144 in the second clamp arm 92, as shown in
[0077] During use, the graft support system 10 may be used to grasp and hold a piece of tissue 12 under tension above a surface 16, which in at least one embodiment as shown in
[0078] Once the piece of tissue 12 is secured and extending between the first and second tissue securement assemblies 35, 36, a needle may be passed through the tissue 12 and the suture 14 pulled tight to place the suture 14 under tension, as shown in
[0079] A method of preparing a graft for implantation or other use may include graft support system 10 being used to grasp and hold a piece of tissue 12 under tension above a surface 16, which in at least one embodiment as shown in
[0080] The method of preparing a graft may include, once the piece of tissue 12 is secured and extending between the first and second tissue securement assemblies 35, 36, passing a needle through the tissue 12 and pulling the suture 14 tight to place the suture 14 under tension, as shown in
[0081] Typical graft tissue preparation required a user to pass the suture from one side to the other side of the graft underneath the graft while trying to maintain tension on the graft. Such was difficult and wasted time. In addition, it was not always possible to maintain tension on the suture. The graft support system 10 and the method of using the graft support system 10 enables a user, such as, but not limited to, a medical professional, to keep tension on a suture in preparation for another stitch when moving a tensioned tag end of the suture from one side of a clamp to a second side of the clamp without having to pass the suture from one hand to another. Rather, the tensioned tag end of the suture can remain in the same hand of the user. Such system and method saves time and greatly increases the likelihood that tension on the suture continue uninterrupted while the user is stitching the graft in preparation for implantation.
[0082] The foregoing is provided for purposes of illustrating, explaining, and describing embodiments of this invention. Modifications and adaptations to these embodiments will be apparent to those skilled in the art and may be made without departing from the scope or spirit of this invention. Upon reviewing the aforementioned embodiments, it would be evident to an artisan with ordinary skill in the art that said embodiments can be modified, reduced, or enhanced without departing from the scope and spirit of the claims described below.