VASCULAR PUNCH

Abstract

The invention discloses a novel vascular punch employing compressive normal force for tissue separation from a targeted vessel. This invention is particularly designed for making a large round hole without massive bleeding in vascular surgery. A clean, non-frayed hole-making guided by the normal force cutting principle is realized using a site-biting punch mechanism. The side-biting vascular punch comprises a U-shaped razor blade cutter, a backstop for receiving the cutter, and a linkage mechanism, forming an aligned line of contact for normal compression force generation and thereby severing tissue out of the targeted vessel.

Claims

1. A vascular punch comprising A sharp razor-like cutter curved in a U-shape form and mounted in a cutter seat; A backstop element attached with a semi-rigid pad for receiving the razor-like cutter; A linkage handler that is able to engage the said cutter seat and said backstop element at its distal end, the said engagement of razor blade edge be in alignment with the said backstop surface, while at the proximal end of the said linkage handler hand gripping force can be applied and transmitted through the linkage elements to the distal cutter end intended for cutting.

2. The vascular punch as defined in claim 1, wherein the said punch is made with a four-bar linkage type handler for hand gripping and cutting force transmission; the said handler comprising a first elongated lever to rigidly joined with the cutter seat at one end, and likewise a second elongated lever affixed with the backstop; the said first and second levers being rotatably hinged into a four-bar parallelogram linkage mechanism to bring said first lever onto said second lever forming a line contact of the razor blade edge with the backstop surface; the said first and second levers being coupled to a pistol-like handle comprising a handset and a trigger, with the second (backstop) lever rigidly connected to the said handset whereas the first (cutter) lever slidably joined with the said trigger of the said handle.

3. The vascular punch as defined in claim 2, said trigger comprising a slot at the distal end receiving a pivot of said first lever, wherein rectilinear motion of the said pivot is allowed within said trigger slot, together with a finger arm for hand gripping and force application, and a spring element to bring said trigger at the cocked position ready for use.

4. The vascular punch as defined in claim 1, said backstop being adjustable, which comprises a semi-rigid pad, a rigid supporting seat and a pad platform provided with a surface orientation mechanism.

5. The vascular punch as defined in claim 4, wherein said surface orientation mechanism comprises a lock screw threaded from the interior side of said backstop, while three set screws threaded oppositely from the exterior side; said three set screws can be adjusted independently to result in a full contact line formation between the razor edge and the semi-rigid pad surface.

6. The vascular punch as defined in claim 1, wherein the said punch is made with a single-pivot linkage type handler for hand gripping and cutting force transmission; the said handler comprising a first elongated lever to rigidly joined with the cutter seat at distal end, and likewise a second elongated lever affixed with the backstop; the said first and second levers being rotatably hinged into a scissors-like linkage mechanism allowing said first (cutter) lever be brought onto said second (backstop) lever, forming a line contact of the razor blade edge with the backstop surface at the distal end of said first and second levers; whereas at the proximal ends of said first and second levers being coupled to a spring element allowing said scissors-like punch be opened at the ready-to-use position.

7. The vascular punch as defined in claim 6, said backstop being adjustable, which comprises a semi-rigid pad, a rigid supporting seat and a pad platform provided with a surface orientation mechanism.

8. The vascular punch as defined in claim 7, wherein said surface orientation mechanism comprises a lock screw threaded from the interior side of said backstop, while three set screws threaded oppositely from the exterior side; said three set screws can be adjusted independently to result in a full contact line formation between the razor edge and the semi-rigid pad surface.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The cutting effectiveness and mechanical principle involved in the present invention, and other objects, features and advantages thereof, may be understood by reference to the following description taken in connection to accompanying drawings in which.

[0029] FIG. 1a is a schematic illustration of a side-biting punch mechanism involving a U-shaped razor cutter and a backstop supporting base for normal force generation upon cutting;

[0030] FIG. 1b is a sectional view of a razor blade engaged in tissue separation wherein normal cutting stress is generated by the applied force F divided by the edge area A;

[0031] FIG. 2a shows Failure Mode A of side-biting punch, wherein the razor edge and backstop surface are misaligned, attributable to the error committed in the manufacturing or installation of the components of the handler, leading to an incomplete cutting line contact and tissue separation;

[0032] FIG. 2b shows Failure Mode B of side-biting punch, wherein the razor edge is wavy due to manufacturing error, leading to an incomplete cutting line contact and tissue separation;

[0033] FIG. 2c shows Failure Mode C of side-biting punch, wherein the backstop surface is not uniformly flat due to manufacturing error, leading to an incomplete cutting line contact and tissue separation;

[0034] FIG. 3a is a representative side-biting cutter design comprising a U-shaped razor blade, a seat and a locking mechanism, shown in a blow-out view;

[0035] FIG. 3b is a representative side-biting cutter design comprising a U-shaped razor blade, a seat and a locking mechanism, shown in a sectional view;

[0036] FIG. 4a is a representative backstop design comprising a solid base, a semi-rigid pad and an adjustable pad platform, shown in a blow-out view;

[0037] FIG. 4b is a representative backstop design comprising a solid base, a semi-rigid pad and an adjustable pad platform, shown in a sectional view;

[0038] FIG. 5 is a blow-out view of a preferred embodiment of a four-bar linkage type side-biting punch design;

[0039] FIG. 6 is a sectional view of a preferred embodiment of a four-bar linkage type side-biting punch design;

[0040] FIG. 7 is a perspective view showing the four-bar-linkage type vascular punch in an open position ready for use;

[0041] FIG. 8 is a perspective view showing the four-bar-linkage type vascular punch in a closed position with side-biting punch action completed;

[0042] FIG. 9 is a blow-out view of another embodiment of a single-pivot type side-biting punch design;

[0043] FIG. 10 is a sectional view of another embodiment of a single-pivot type side-biting punch design;

[0044] FIG. 11 is a perspective view showing a combined use of the present side-biting punch invention in conjunction with a partial clamp to achieve hemostasis during hole-making in a vascular wall; and

[0045] FIG. 12 shows the finite distance between the cutting line and the hemostatic zone created by partial clamping of a vessel.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] Referring to FIG. 5 and FIG. 6 the four-bar linkage type side-biting vascular punch comprises a razor-blade cutter 10, a backstop 20, a cutter lever 30, a backstop lever 40, a pair of hinge bars 50, and a handler 60. The razor-blade cutter further comprises a U-shaped razor-blade 11, a seat 12 and a locking mechanism 13. As detailed in FIG. 3a, and FIG. 3b, the seat 12 is screwed fixed with cutter 10 by a screw 14, and the razor blade 11 is squeezed against the side flange of said seat 12 using a lock plate 13. In the installation of the razor blade 11, the dull edge of the blade is first placed in contact with the corner of the side flange of seat 12, and then the blade side wall is squeezed and retained in position by the lock plate 13, followed by fixing the lock plate 13 using two lock screws 15. The cutter 10 and backstop 20 are blood-contacting, hence preferred to be made single-use to eliminate the possibility of infection. When integrated, the cutter 10 becomes an integral extension of the cutter lever 30, requiring a tight assembly tolerance to assure the parallelism of the razor blade edge 11 to the cutter lever 30.

[0047] The backstop 20, however, includes a supporting base 21 glue attached with a semi-rigid pad 22. In FIG. 4a and FIG. 4b illustrated the construction of said backstop 20 Supporting base 21 is connected with the backstop 20 by using a lock screw 23, further augmented by three set screws 24 for surface orientation adjustment so as to attain the optimized line of contact during cutting. Analogous to the integration of cutter 10 to cutter lever 12, the alignment in assembly of backstop 20 and backstop lever 40 is required to be within certain tight tolerance also.

[0048] The backstop lever 40 is rigidly connected to the handler 60 and the cutter lever 30 is slidably coupled with the handler 60 in a pivot-in-a-slot manner. A pair of hinge bars 50, each comprising a short pin with two through holes 51 bored at its two ends, are rotatably joined with the cutter lever 30 and backstop lever 40, forming a four-bar-linkage mechanism. The rotational motion of the hinge bar is provided through the use of two pairs of pivot 52 and its lock screw 53, connecting together cutter lever 30 and backstop lever 40 via a rotational constraint.

[0049] The four-bar-linkage in cocked, ready-to-use open position and retracted, cutting completion closed position are illustrated in FIG. 7 and FIG. 8, respectively. This four-bar-linkage mechanism gives rise to a translational motion of cutter lever 30 parallel to backstop lever 40, by way of a simultaneous rotation of the two hinge bars 50. Parallelism between the joined levers 30 and 40 holds the key of an effective side-biting punch intended to remove vascular tissue in surgery. Parameters influencing the parallelism include the pivot hole positions drilled on hinge bars 50, cutter 30 and backstop levers 40; the fitting tolerance of hinges 50 assembled with the rotationally engaged parts 30, 40; and the rigidity of the connected levers 30, 40, when subject to cutting force generated from manually gripping the trigger 61 toward handset 62 of handler 60.

[0050] U-beam structure is preferred for constructing cutter lever 30 and backstop lever 40, because these thin-walled structures may optimize the weight penalty against maximal bending stiffness attained for the lever rigidity. Tigger 61, rotationally mounted on the handler 60 by a pivot 63 and its pivot screw 64, constitutes a mechanism for imparting cutting force onto and translational motion associated with the cutter lever 30 of the said side-biting punch. The cutter lever 30 is joined with the slot in trigger 61 by a pivot 65 fixed on the cutter lever 30 by a screw 66, forming a pivot-in-a-slot relationship with the distal portion of the trigger 61, wherein a slot is provided for accommodating the pivot 65.

[0051] The cutter lever 30, hence, can be pushed forward from the cocked position to the closed position, and vice versa from the closed position back to the cocked position. Force required for forward motion is provided by hand gripping whereas backward motion by the recoil force generated by a leaf spring 67 pair whose legs are fixed by screw 68 on the handset 62 and the trigger 61, respectively. As trigger 61 is actuated with circular motion induced, centered around pivot 63, the distal slot of the trigger 61 guides the cutter lever 30 moving forward or backward and drives the actuated pivot 64 sliding in the slot, consequently results in the rotation of the hinge bars 50 and brings the cutter lever downward or upward correspondingly. Hand gripping trigger 61 toward handset 62 initiates the cutting action and brings cutter lever 30 downward, until razor blade edge 11 lands on the backstop surf ace for cutting the compressed tissue underneath the contact line. Upon completion of cutting, the user holds the present invention in the closed position, hence securing the removed vascular tissue and letting it well captured in the space defined by the inner side of the razor blade 11 and the backstop 20. Consequently, tissue can be safely retrieved after pulling the present invention outside of the patient's body.

[0052] Another embodiment of the present invention is via a single-pivot type mechanism, as illustrated in FIG. 9 and FIG. 10. This said single-pivot type side-biting punch comprises a razor blade cutter 70, a backstop 80 preferred to be adjustable, a cutter lever 90, a backstop lever 100, a leaf spring pair 101, and a pivot 102 and its lock screw 103. The razor blade cutter 70 comprising a razor blade 71, a seat 72, a lock plate 73, a lock screw 74, and two set screws 75, is of the same design as previously described in the four-bar-linkage side-biting punch. This razor blade cutter 70 is rigidly integrated with the distal end of the cutter lever 90, and so is the backstop 80 to the backstop lever 100. Cutter lever 90 and backstop lever 100 are joined together by a pivot 102 and a pivot screw 103, into a scissors-like structure that allows gripping force to be amplified and transmitted to the razor cutting edge. Such single-pivot type side-biting punch aligns the contact line of the razor edge with the backstop surface when the said punch is brought into the closed position for cutting.

[0053] The adjustable backstop 80 is of the same design as the backstop 20 described previously in the four-bar-linkage realization. For this adjustable backstop 80, pad orientation adjustment can be attained by, but not limited to, a pad platform 82 glue attached with the semi-rigid pad 81, the pad platform 82 being initially loosely joined with the supporting base of backstop 80 using a lock screw 83 threaded in from the exterior side of the pad platform 82 There are three additional set screws 84, each occupying a vertex of a triangle, that are threaded in the supporting base of backstop 80 for surface orientation adjustment. By independently adjusting the depth of the threaded set screws 84 together with the lock screw 83, the contact line of cutting can be re-oriented to result in a full contact of the razor edge with the semi-rigid pad 81, hence enhancing the cutting effectiveness.

[0054] Assurance of hemostasis during large vascular hole-making is of paramount importance to a surgical operation. Partial occlusion of a blood flow in artery or vein has been generally achieved using partial clamps. The present punch invention can conveniently work together with those clinically proven partial clamps to prevent bleeding from occurring, either during or after the hole punching. In FIG. 11 and FIG. 12 the combined use of the present invention with the partial clamp is demonstrated. First, partial clamp is applied to create a region excluded from the blood flow. Then, a side-biting vascular punch is employed to cut a piece of tissue out of this hemostatic region. The cutting line shown in FIG. 12 indicates that there is still enough margin between the hemostatic line of clamping to the periphery of the hole punched. End-to-side anastomosis can thus be safely performed by running suturing the graft end with the hole periphery, while partial clamp is locked in place to exclude the bleeding concern.

[0055] It has been generally known to vascular surgeons that the contemporary vascular punch, in the anvil-in-a-tube-cutter form, is principally based on shearing force generated via a rectilinear or a helical engagement of anvil with its receiving tube cutter Tissue separation, as a matter of fact, can only be attained for hole diameter less than 6 mm or so. For larger hole-making in a vessel, the required force increases substantially beyond the human gripping strength limit and hemostasis is generally difficult to maintain. Often, in the practical application, surgeon ought to apply numerous incremental side-biting moves on the periphery of a small hole until a desired larger hole size is achieved. As a result, the work load is high but the quality of the punched hole is not necessarily guaranteed. The present invention envisions a side-biting punch design based on a completely different normal force tissue separation principle, which can also work conveniently with partial clamp to maintain hemostasis during and after hole-making. While two embodiments are introduced and described, it is understood that those skilled in the art may devise various modifications or equivalents without departing from the spirit and scope of the invention as defined by the appended claims.