Biological construct delivery system

Abstract

A delivery system for delivering a biological construct to a target treatment site in a patient includes a delivery or grasper that supports the construct or patch between grasper ends, a gripping pad. The deliverer includes forceps or arms between which the construct can be releasably received. The delivery device urges the construct through the slotted cone, and when the construct is passing through the cone, the construct is wound and then protrudes from the slotted cone via an insertion end that delivers the implant or construct through the cannula to the target surgical site.

Description

[0001] Cross-reference to related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 517,761, filed on August 4, 2023. Technical Field

[0002] This invention relates to the field of delivery devices for delivering biological constructs to target therapeutic sites within a patient. Background Technology

[0003] Compared to traditional surgery, endoscopic surgery capable of delivering bio-constructs offers significant advantages. In such procedures, the precise positioning and placement of bio-constructs often presents challenges, either inaccurately or due to difficulties in execution. Accurately delivering bio-constructs to the appropriate location at the site of a tear in the target tissue can promote healing. Summary of the Invention

[0004] The apparatus and method described below improve the placement accuracy of bio-constructs in endoscopic surgery by releasing, re-grasping, or repositioning bio-constructs within the patient. The delivery system includes a delivery device or gripper that supports the construct or patch between the gripper's end and clamping pads. The delivery device includes forceps or an arm that releasably accommodates the construct between the arm and the clamping pads. The delivery device pushes the construct through a grooved cone, where it is coiled as it passes through the cone and then extends from the grooved cone via an insertion end that delivers the implant or construct through a cannula to the target surgical site. This bio-construct delivery system enables better insertion and positioning of patches or constructs within the target surgical space. The delivery device equipped with the bio-construct delivery system allows for the release and re-grasping of the bio-construct, resulting in easier operation and use. Attached Figure Description

[0005] Figure 1 For biological construct delivery systems; Figure 2 Details of the distal end of the delivery device or gripper in a biological construct delivery system; Figure 3 A delivery device for a biological construct delivery system with an alternative handle; Figure 4 A delivery device for a biological construct delivery system with a clamping pad attached to the arm body; Figure 5 A top view of the delivery device for the biological construct delivery system; Figure 6 A side view of the delivery device for the biological construct delivery system; Figure 7 , Figure 8 , Figure 9A variety of expander pads that can be used with the delivery unit of a build delivery system; Figure 10 , Figure 11 A delivery device for a clamping pad with a flat needle sewing machine or a crochet needle sewing machine. Detailed Implementation

[0006] Figure 1 A biological construct delivery system 1 is provided. The system includes a delivery device 2, a delivery cone 3, an obturator, a sleeve 4, and a biological construct sheet 5 disposed within the delivery device. The delivery device or gripper 6 includes a handle 7 and a connecting rod 8 extending from the handle; the delivery device has a proximal end and a distal end. The connecting rod extends longitudinally from the handle and connects at its distal end to a first arm 9 and a second arm 10 (e.g., ...). Figure 2 (As shown) The delivery device also includes a support pad 11 having a first or upper piece and a second or lower piece, the first piece of which is releasably connected to one arm of the delivery device. A bio-construct piece 5 is releasably fixed between the first and second pieces of the delivery device and subsequently placed between the first and second arms of the delivery device for delivery to the target surgical space within the patient. The delivery cone 3 has a proximal end and a distal end, and the cone has a longitudinal through groove 12, its proximal end being open, and the overall shape tapering distally towards the distal end in a cone or funnel shape. This bio-construct delivery system also includes a cannula 4, into which the assembled delivery cone is inserted.

[0007] Figure 2 Details of the distal end of the deliverer or gripper 6 of the bio-construct delivery system. The deliverer is a device used to guide the bio-construct and place it on the target treatment site. The deliverer includes a handle 7 (such as...). Figure 1 (As shown) and a connecting rod 8 extending longitudinally from the handle, the distal end of the connecting rod having a first arm 9 and a second arm 10. The first and second arms are made of an elastic material such as a polyester film (mylar) and are elastically openable and closable. The first and second arms secure a support pad 11, which includes a first elastic polymer sheet 13 and a second elastic polymer sheet 14, which help secure the bio-construct or patch between the support pads. Once in place, the clamping pad releases the implant to secure it, ensuring that the implant does not slip on the arms as it is wound and inserted into the patient through the cone. Once in the desired position, the clamping pad locks, also securing the bio-construct or implant firmly between the elastic arms of the delivery device. However, the support pad with the elastic polymer sheet can release and re-grasp the patch by opening / closing its own elastic polymer sheet and moving the bio-construct within the surgical area, thereby repositioning the bio-construct before final placement.

[0008] The expansion pad has a layered structure. The first or upper sheet 13 is an elastic polymer layer, such as polyester film (PETG), with a thickness between 1 and 15 mils. The first sheet may also include an attachment feature 15 for attaching the expansion pad to the first arm of the gripper. The expansion pad also includes a second or lower sheet 14, which may be made of any elastomeric material, such as adhesive soft TPE, silicone rubber, polyester film, PET, or spring memory polymer. The first and second sheets can be bonded together with a biocompatible adhesive. Both the first and second sheets may include at least one textured clamping portion 16 on its surface for better securing the bio-construct. The clamping surface may be made of polyurethane, and the surface of the polyurethane layer may have a molded texture. The textured polyurethane clamping layer may be laminated onto the polymer layer of the clamping pad. The first and second sheets of the expansion pad may be of any shape, but are preferably of the same shape. The expansion pad, made of elastic polymer, enables the repositioning of the bio-construct. During the process of pushing the bio-construct to the target treatment area, the expansion pad can firmly fix the bio-construct. Once the target position is reached, the metal clamps can be manipulated to open and close, allowing the bio-construct to be releasably repositioned from the target treatment position until it is in the correct position before it is sutured and fixed to the treatment site.

[0009] Figure 3 A delivery device for a biological construct delivery system with an alternative handle. The delivery device includes a flat, sliding grip handle with an opening / closing knob 17 for opening and closing an arm at the distal end of an elongated rod. The elongated rod includes a first arm and a second arm operated by an opening / closing slider located at the distal end of the delivery device, and the arm is connected to a spreading pad, in which a biological construct is accommodated between a first sheet and a second sheet of the spreading pad.

[0010] Figure 4 The delivery device 6 of the biological construct delivery system has a first clamping pad or upper clamping pad connected to the delivery device arm body, and the clamping pad is connected to the first arm body of the delivery device via attachment feature 16.

[0011] Figure 5 This is a top view of the delivery device for the biological construct delivery system. The clamping pad shown is tapered at the proximal end and fixed to the arm of the delivery device, which facilitates the pushing and retrieval of the implant through the cannula.

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

[0013] Figure 7 , Figure 8 , Figure 9 A variety of expansion pads that can be used with the delivery unit of a building block delivery system. Figure 7The expansion pad is made of an elastic material, such as silicone rubber or thermoplastic elastomer (TPE), and is overmolded onto the nickel-titanium alloy wire ring 18. Figure 8 The support pad with a traction structure has molded protrusions distributed at predetermined intervals on its surface to form a textured clamping part 16. Figure 9 The expansion pad includes an O-ring 19, which has a central clamping area instead of the traditional flat sheet structure. All of the above structures enable the sheet implant to flatten smoothly.

[0014] Figure 10 , Figure 11 A delivery device for a clamping / spreading pad 11 with a plain needle suturer 20 or a hook needle suturer 21. The delivery device has a sheet-like push structure equipped with a suturer for suturing and securing a biological patch or biological construct to a tendon. Figure 10 It is a hook suture device that allows sutures to be looped into human tissue from the top / bursa side; Figure 11 It is a sheet delivery device equipped with a flat needle suture, which can be inserted into the suture from the bottom / joint side of the rotator cuff tendon.

[0015] In use, an operating channel is created through a surgical incision to access the target tissue area. The surgical space can be established percutaneously using a dissecting instrument or expanded with saline solution. A cannula is inserted into the surgical space, and the delivery cone and obturator are inserted into the cannula. The obturator is then removed from the cannula. The arms of the delivery device are maneuvered into the open position, and the bio-construction piece is placed between the open arms. The arms are then closed to secure the bio-construction within. The bio-construct piece is clamped between the arms of the delivery device, connecting the clamping pad of the bio-construct piece to the arm with the expanding pad. The arm clamps the middle of the bio-construct piece and forms a support post, allowing the bio-construct piece to coil around the support post as it passes through the grooved delivery cone. The fixed bio-construct piece is then placed into the delivery cone for coiling insertion. The arm of the delivery device is advanced into the grooved delivery cone; as it is pushed, the delivery channel allows the bio-construct piece to gradually coil until it is completely coiled within the delivery cone. It is then pushed out of the delivery cone, through the cannula, and into the surgical space. Next, the grooved delivery cone is retracted from the cannula and removed from the delivery device's connecting rod through the groove in the delivery cone. The delivery device can be removed through the cannula, offering significant advantages compared to existing technologies. The grooved funnel-shaped cone can be used with a second cannula or as a removable percutaneous cannula without the need for a second cannula. Remove the slotted delivery cone from the cannula from above the delivery device; the delivery device's arm continuously and firmly clamps the construct or patch, allowing the surgeon constant control over the sheet construct and repositioning it as needed for fixation procedures; the clamping pad, with its traction surface, gently and firmly clamps the bioconstruct, and is flexible and flattenable, flattening the bioconstruct sheet to prepare it for suture fixation in the patient; place the flattened bioconstruct sheet on the tendon and perform the fixation procedure; loosen the delivery device's clamping mechanism, slide it to a new position, and then re-clamp it. The surgeon can release and re-grasp the bioconstruct sheet during positioning and fixation to maximize control over it; perform additional fixation procedures as needed; open the delivery device and slide it away from the fixed bioconstruct; close and lock the delivery device, then remove it through the cannula.

[0016] Although preferred embodiments of the apparatus and method of the present invention are described in conjunction with their application scenarios, these embodiments are only used to illustrate the principles of the invention. The technical features of each embodiment can be combined to achieve synergistic effects, and each beneficial technical feature can be applied individually or in combination. Those skilled in the art can design other embodiments and structural forms without departing from the spirit of the invention and the scope of the appended claims.

Claims

1. A biological construct delivery system, comprising: A delivery device having a proximal end and a distal end, the delivery device including a handle and an elongated rod extending longitudinally from the handle and connected to a first arm and a second arm extending from the elongated rod from the distal end of the delivery device; An expansion pad having a first sheet and a second sheet, the first sheet of the expansion pad being releasably connected to a first arm of the delivery device, and the second sheet being releasably attached to a second arm of the delivery device; A delivery cone having a proximal end and a distal end, and a longitudinal through groove along the delivery cone, the proximal end of the delivery cone being shaped to introduce a biological construct into the delivery cone; as well as A cannula, releasably attached to the distal end of a delivery cone, wherein the delivery cone is shaped to be inserted into the cannula; The biological construct is releasably fixed between the first and second pieces of the expandable pad.

2. The biological construct delivery system according to claim 1, wherein, The first and second sheets of the stretch pad are made of polyester film.

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

4. The biological construct delivery system according to claim 2, wherein, The first and second sheets of the expansion pad also include a textured polyurethane interlayer laminated on the surface of each sheet.

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

6. The biological construct delivery system of claim 1, further comprising a closure device configured to be inserted into the delivery cone.

7. The biological construct delivery system according to claim 1, wherein, The handle of the delivery device also includes an opening and closing slider, which controls the opening and closing of the delivery device's arm.

8. A delivery device for a biological construct system, comprising: handle; A slender rod extending longitudinally from a handle, and having a first arm and a second arm at its ends; as well as An expansion pad, comprising a first sheet and a second sheet, the first sheet of the expansion pad being releasably connected to a first arm of the delivery device, and the second sheet being releasably attached to a second arm of the delivery device.

9. The delivery device according to claim 8, wherein, The first and second sheets of the stretch pad are made of polyester film.

10. The delivery device according to claim 9, wherein, The first and second sheets of the expansion pad also include a textured polyurethane interlayer laminated on the surface of each sheet.

11. The delivery device according to claim 8, wherein, The first and second pieces of the expanding pad are the same size.

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

13. The delivery device according to claim 8, wherein, The handle of the delivery device is also equipped with an opening and closing slider, which can control the opening and closing of the delivery device's arm.

14. A method for delivering a biological construct to a target delivery region, comprising the following steps: Establish operational pathways to the target organizational area; Insert the cannula into the surgical space, then insert the delivery cone and obturator into the cannula, and remove the obturator when the delivery cone reaches the target position; Provide a delivery device, the delivery device comprising: handle; A slender rod extending longitudinally from a handle, and the ends of the slender rod having a first arm and a second arm; and An expansion pad, the expansion pad including a first sheet and a second sheet, the first sheet of the expansion pad being releasably connected to a first arm of the delivery device, and the second sheet being releasably attached to a second arm of the delivery device; Place the biological construct within the expansion pad; The delivery device containing the biological construct is placed inside the delivery cone. By pushing the delivery device through the delivery cone, the biological construct is wound around the delivery cone, passes through the cannula, and is then pushed into the surgical space. The delivery arm is manipulated to open and close to reposition the biological construct until it is in the desired position; Fix the biological construct at the desired location; Open the arms of the delivery device and slide the delivery device away from the fixed biological construct; Remove the delivery device through the sleeve; and Remove the sleeve.

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