Biological construct delivery system

Abstract

A system for delivering biological constructs to a targeted treatment site within a patient's body. The delivery system comprises a passer or gripping forceps that supports the construct or patch at the tip of the gripping forceps between gripping pads. The passer comprises forceps or an arm that detachably holds the construct between the arm and the gripping pad. The passer advances the construct through a slotted cone, during which the construct is wound up and then ejected from the slotted cone via an insertion tip, which delivers the implant or construct to the desired surgical site via a cannula.

Description

Technical Field

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[0001] This application claims priority based on U.S. Provisional Application 63 / 517,761, filed on August 4, 2023.

[0002] The invention described below relates to the field of delivery devices for biological constructs to a target treatment site within a patient's body.

Background Art

[0003] Endoscopic surgery that enables the delivery of biological constructs offers significant advantages over conventional surgery. The positioning and placement of biological constructs in such procedures have been inaccurate or difficult to perform. By accurately delivering the biological construct above the desired tissue damage site and placing it in a favorable position, the healing of the damaged tissue is promoted.

Summary of the Invention

[0004] The devices and methods described below improve the placement of biological constructs during endoscopic surgery by enabling the release, re-grasping, or repositioning of biological constructs within a patient's body. This delivery system includes a pusher or grasping forceps that supports a construct or patch between grasping pads at the tip of the grasping forceps. The pusher includes forceps or an arm that detachably holds the construct between the arm and the grasping pad. The pusher advances the construct through a slotted cone, and as the construct advances through the cone, it is wound up and then discharged from the slotted cone through an insertion tip, which passes the implant or construct through a cannula to the desired surgical site. This biological construct delivery system improves the accuracy of introducing and placing a patch or construct into a desired surgical space. This biological construct delivery system includes a pusher that can release and re-grasp the construct to enhance the handling and operability of the biological construct.

Brief Description of the Drawings

[0005] [Figure 1] This illustrates a biological construct delivery system. [Figure 2] Details of the distal end of the passer or grasping forceps in a biological construct delivery system are shown. [Figure 3] This shows a passer in a biological construct delivery system with an alternative handle. [Figure 4] This image shows a passer in a biological construct delivery system with a gripping pad attached to the passer arm. [Figure 5] A plan view of the passer in the biological construct delivery system is shown. [Figure 6] A side view of a passer in a biological construct delivery system is shown. [Figure 7] This shows various spreader pad sheets used in passers of a structure delivery system. [Figure 8] This shows various spreader pad sheets used in passers of a structure delivery system. [Figure 9] This shows various spreader pad sheets used in passers of a structure delivery system. [Figure 10] This shows a passer having a gripping pad equipped with a flat needle or crochet stitcher. [Figure 11] This shows a passer having a gripping pad equipped with a flat needle or crochet stitcher.

[0006] Figure 1 shows a biological construct delivery system 1. The system comprises a passer 2, a delivery cone 3 and obturator, a cannula 4, and a biological construct sheet 5 positioned within the passer. The passer or grasping forceps 6 comprises a handle 7 and a mounting rod 8 extending from the handle. The passer has a proximal end and a distal end. The mounting rod extends longitudinally from the handle and connects at its distal end to a first arm 9 and a second arm 10 (see Figure 2). The passer further comprises a grasping or spreader pad 11 having a first sheet (upper sheet) and a second sheet (lower sheet). The first sheet of the spreader pad is detachably attached to the arms of the passer. The biological construct sheet 5 is detachably fixed between the first and second sheets of the passer and is then positioned between the first and second arms of the passer for delivery to the desired surgical space within the patient's body. The delivery cone 3 has a proximal end and a distal end. The cone is provided with a longitudinally oriented slot 12. The cone is open at the proximal end and tapers towards the distal end in a conical or funnel shape. The biological construct delivery system further comprises a cannula 4. The delivery cone is inserted into the cannula in an assembled state.

[0007] Figure 2 shows details of the distal end of the passer or grasping forceps 6 of the biological construct delivery system. The passer is an instrument for guiding and positioning a biological construct to the desired treatment site. The passer comprises a handle 7 (see Figure 1) and a mounting rod 8 extending longitudinally from the handle. The distal end of the mounting rod is provided with a first arm 9 and a second arm 10. The first and second arms are made of an elastic material such as Mylar and are operated to open and close by a spring. The first and second arms secure a spreader pad 11 containing a first elastic polymer sheet 13 and a second elastic polymer sheet 14. The spreader pad sheets contribute to securely holding the biological construct or patch between the spreader pads. The grasping pad securely fixes the implant in place once in place to ensure that it does not slip around the arms when it is wound up to insert through the cone to introduce the implant into the patient. The grasping pad lock securely holds the biological construct or implant between the elastic arms of the passer when positioned in the preferred location. However, spreader pads equipped with elastic polymer sheets allow for the release and re-grasp of the patch, as this enables the opening and closing of the elastic polymer sheet and the movement of the biological structure within the surgical area, thereby allowing for repositioning of the biological structure before final placement.

[0008] The spreader pad is shown in layers. The first or upper layer sheet 13 is an elastic polymer layer. For example, the first sheet may be made of Mylar (PETG) and may have a thickness of 1 to 15 mils. The first sheet may also be provided with a mounting portion 15 for attaching the spreader pad to the first arm of a gripping forceps. The spreader pad further comprises a second or bottom sheet 14. The second sheet can be formed from any elastomer material such as adhesive and flexible thermoplastic elastomer (TPE), silicone, Mylar, PET, or spring memory polymer. The first and second sheets can be bonded to each other via a biocompatible adhesive between the sheets. Both the first and second sheets may have at least one surface having a textured grip 16 for more securely holding a biological construct. The grip may be formed from urethane with a texture molded into the polymer sheet surface. The textured urethane grip layer may be laminated to the polymer layer of the grip pad. The first and second spreader pad sheets may be of any shape, but are preferably the same shape. The elastic polymer spreader pad allows for the repositioning of the biological structure. The spreader pad securely holds the biological structure as it is advanced to the desired treatment area. However, once the desired position is reached, the metal clamp arm can be operated to open and close it, allowing the biological structure to be repositioned detachably from the desired treatment site until it is in the correct position before being stapled to the treatment site.

[0009] Figure 3 shows a passer of a biological construct delivery system with an alternative handle. The passer is equipped with a flat slider grip handle. The handle is provided with an opening / closing slider 17, which opens and closes an arm at the distal end of an elongated rod. This arm includes a first arm and a second arm, which are actuated by the opening / closing slider at the distal end of the passer. The arms are connected to a spreader pad and hold the biological construct between the first and second sheets of the spreader pad.

[0010] Figure 4 shows a passer 6 of the biological construct delivery system, with a first or upper gripping pad attached to the passer arm. The gripping pad is attached to the first arm of the passer via a mounting portion 15.

[0011] Figure 5 shows a plan view of the passer of the biological construct delivery system. It shows a gripping pad with a tapered proximal end, fixed to a passer arm to facilitate the advancement and removal of the implant through the cannula.

[0012] Figure 6 shows a side view of the passer of the biological construct delivery system. This shows the first and second arms, to which the elastic polymer sheets are attached, in an open state.

[0013] Figures 7, 8, and 9 show various spreader pad sheets used in passers of a construct delivery system. Figure 7 shows a spreader pad made of an elastic material such as silicone or TPE, overmolded onto a Nitinol wiring 18. Figure 8 shows a spreader pad with a traction function in the shape of molded protrusions that create textured grips 16 arranged at predetermined intervals on the grip pad surface. Figure 9 shows a spreader pad with an O-ring 19 having a central grip area instead of a flat sheet. All of these allow the sheet implant to be easily rolled up and placed in a flat position.

[0014] Figures 10 and 11 show passers equipped with a gripping pad or spreader pad 11 and a flat needle 20 or crochet hook 21 stitcher. These passers are equipped with a sheet passer and stitcher for securing biological pathways or structures to tendons. Figure 10 shows a crochet hook that loops the suture into biological tissue from the superior / bursal side. Figure 11 shows a stitcher equipped with a sheet passer and a flat needle that passes the suture from the posterior / articular side of the rotator cuff tendon.

[0015] For use, a surgical incision is made to ensure access to the target tissue area. The surgical space may be formed percutaneously using dissection instruments or inflated with saline solution. The cannula is inserted into the surgical space. The delivery cone and obturator are inserted into the cannula. The obturator is then removed from the cannula. The arms of the passer are fixed in the open position, and the biological construct sheet is placed between the open arms. Next, the arms are closed to secure the biological construct between them. The biological sheet construct is grasped between the arms of the passer and clamped so that the gripping pads of the biological sheet construct attach to the arms of the spreader pad. The arms clamp the central part of the biological construct, forming a pole for the biological sheet construct to wrap around as it passes through the slotted delivery cone. The secured sheet is placed inside the delivery cone and rolled up for insertion. The passer arm is inserted into the slotted delivery cone, and as the arm advances, the delivery tunnel gradually wraps around the biological structure until it is fully wrapped within the delivery cone, then passes through the cone and through the cannula into the surgical space. The slotted delivery cone is then pushed back from the cannula and removed by passing it through the slots in the delivery cone over the passer's mounting rod. The passer can be removed through the cannula, which is an advantage over conventional systems. The slotted funnel can be used with a second cannula or as a removable percutaneous cannula without a second cannula. The slotted delivery cone is removed from the cannula on the passer. The passer arm securely holds the structure or patch so that the surgeon can maintain control of the sheet and reposition the sheet during fixation preparation. The pad has a traction surface that gently and securely holds the biological structure. The pad is elastic and resilient and lies flat so that it flattens the biological structure sheet and prepares it for fixation to the patient with staples. The unfolded biological sheet construct is positioned and fixed onto the tendon. Release the passer clamp, slide it to a new position, and then clamp it again. The surgeon can maintain maximum control over the biological sheet by releasing and re-grasping it during the positioning and fixation process. Apply additional fixation as needed. Open the passer and slide it away from the fixed biological structure. Close and lock the passer, then remove it through the cannula.

[0016] Preferred embodiments of the apparatus and methods have been described with reference to the environment in which they were developed, but these merely illustrate the principles of the invention. Components of various embodiments can be incorporated into other embodiments to obtain the advantages of combining those elements with other embodiments. Furthermore, various beneficial features can be adopted in embodiments individually or in combination with each other. It is possible to devise other embodiments and configurations without departing from the spirit of the invention and the scope of the appended claims.

Claims

1. A passer having a proximal end and a distal end, comprising a handle, and a passer having an elongated rod extending longitudinally from the handle, and connected to a first arm and a second arm protruding from the elongated rod at the distal end of the passer, A spreader pad having a first sheet and a second sheet, wherein the first sheet of the spreader pad is configured to be detachably attached to the first arm of the passer, and the second sheet of the spreader pad is configured to be detachably attached to the second arm of the passer, A delivery cone having a proximal end and a distal end, and comprising a slot that penetrates longitudinally along the delivery cone, wherein the proximal end of the delivery cone is shaped for introducing a biological construct into the delivery cone, A cannula comprising a delivery cone having a shape that can be introduced into the cannula, and a cannula detachably attached to the distal end of the delivery cone, The biological construct is detachably fixed between the first and second sheets of the spreader pad. Biological construct delivery system.

2. The biological construct delivery system according to claim 1, wherein the first sheet and the second sheet of the spreader pad are made of Mylar (registered trademark).

3. The biological construct delivery system according to claim 1, wherein the thickness of the first sheet and the second sheet of the spreader pad is 1 to 15 mils.

4. The biological construct delivery system according to claim 2, wherein the first and second sheets of the spreader pad further comprise a textured urethane grip layer laminated on the surface of each sheet.

5. The biological construct delivery system according to claim 1, wherein the first sheet and the second sheet of the spreader pad are the same size.

6. The biological construct delivery system according to claim 1, further comprising an obturator configured to be inserted into the delivery cone.

7. The biological construct delivery system according to claim 1, wherein the handle of the passer further comprises an opening / closing slider that can be operated to open and close the arm of the passer.

8. The handlebars and An elongated rod extending longitudinally from the handle, having a first arm and a second arm at its end, A spreader pad comprising a first sheet and a second sheet, wherein the first sheet of the spreader pad is configured to be detachably attached to the first arm of the passer, and the second sheet is configured to be detachably attached to the second arm of the passer, A passer equipped with for use in biological construct systems.

9. The passer according to claim 8, wherein the first sheet and the second sheet of the spreader pad are made of Mylar.

10. The passer according to claim 9, wherein the first sheet and the second sheet of the spreader pad further include a textured urethane grip layer laminated on the surface of each sheet.

11. The passer according to claim 8, wherein the first sheet and the second sheet of the spreader pad are the same size.

12. The biological construct delivery system according to claim 1, wherein the thickness of the first sheet and the second sheet of the spreader pad is 1 to 15 mils.

13. The passer according to claim 8, wherein the handle of the passer further comprises an opening / closing slider that can be operated to open and close the passer arm.

14. Steps to establish access to the target organizational domain, The steps include inserting a cannula into the surgical space, then inserting a delivery cone and an obturator into the cannula, and removing the obturator when the delivery cone reaches the target position, The step of providing a passer, The handlebars and An elongated rod extending longitudinally from the handle, having a first arm and a second arm at its end, A step of providing a passer comprising a spreader pad including a first sheet and a second sheet, wherein the first sheet of the spreader pad is configured to be detachably attached to the first arm of the passer, and the second sheet is configured to be detachably attached to the second arm of the passer, The steps include placing the biological construct within the spreader pad, The steps include: placing the passer equipped with the biological structure within a delivery cone, advancing the passer into the delivery cone and into the cannula, thereby winding the biological structure through the delivery cone and advancing it into the surgical space; The steps include opening and closing the passer arm to reposition the biological structure until it reaches a desired position, The steps include fixing the biological structure at the desired position, The steps include opening the arms of the passer and sliding them away from the fixed biological structure, The steps include removing the passer through the cannula, The step of removing the cannula, A method for delivering a biological construct to a target delivery region, comprising the following features.

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