US20200060800A1 - Biomedical patch and delivery system - Google Patents
Biomedical patch and delivery system Download PDFInfo
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- US20200060800A1 US20200060800A1 US16/562,936 US201916562936A US2020060800A1 US 20200060800 A1 US20200060800 A1 US 20200060800A1 US 201916562936 A US201916562936 A US 201916562936A US 2020060800 A1 US2020060800 A1 US 2020060800A1
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- Prior art keywords
- patch
- flexible patch
- tissue
- tissue defect
- biodegrade
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
- A61F2002/0072—Delivery tools therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/16—Materials with shape-memory or superelastic properties
Definitions
- the human brain and spinal cord are surrounded by a system of three protective membranes known as the meninges: the pia mater, the arachnoid mater, and the dura mater.
- the meninges serve to maintain a layer of cerebrospinal fluid around the brain and spinal cord, protect the brain and spinal cord from trauma/abrasion, and support extra-cortical vasculature carrying blood to/from the brain.
- the dura mater is a thick fibrous membrane lining the inner surface of the skull and spinal column which forms a water-tight sac around the central nervous system and serves as the primary barrier between nervous tissue and the underlying bone.
- the dura mater may be vastly resected or completely removed (defects >1000-1500 cm 2 ) to allow for cortical decompression or removal of diseased tissues. In all cases, regardless of the size or location of the dural defect, the dura mater must be repaired intraopertatively in order to restore the protective covering of the brain and reestablish the continuous layer of cerebrospinal fluid around the central nervous system. To facilitate this repair surgeons employ a type of surgical membrane or patch known as a “dural substitute.”
- FIG. 10 illustrates two patches adhered together according to one embodiment.
- FIG. 19 b illustrates a mechanism by which a patch delivery system holds and releases a patch according to one embodiment.
- FIG. 21 b illustrates a mechanism by which a patch delivery system holds and releases a patch according to one embodiment.
- FIG. 24 illustrates a method of implanting a patch to a tissue defect using a patch delivery system according to one embodiment.
- FIG. 28 illustrates a method of implanting a pre-adhered multi-laminar repair matrix to a tissue defect using a patch delivery system according to one embodiment.
- dural substitutes Multiple types are available for use in repairing dural defects created during routine neurosurgical procedures. Yet, despite the present availability of dural substitutes, a substantial need exists for new dural substitutes that are easier to handle, increasingly reliable and suturable, increasingly compliant, faster to implant, effectively seal leaks in the dura, promote improved patient outcomes, and eliminate injurious side effects and complications.
- the size, shape and/or geometry of the top patch 140 may be different from the bottom patch 120 . In other embodiments, the size, shape and/or geometry of the top patch 140 may be the same as the bottom patch 120 . In some embodiments, the bottom patch 120 may be smaller than the top patch 120 . The small size of the bottom patch 120 may allow the bottom patch 120 to be inserted through the tissue defect 110 . With the larger size of the top patch 140 , a larger portion of the patch 140 may contact the tissue, thus promoting cellular ingrowth and sealing of the tissue defect 110 . In addition, in order to prevent foreign body response, inflammatory response, and/or allergic response, the size of the top patch 140 may be limited.
- the thickness of the top patch 140 may be different from the bottom patch 120 . In other embodiments, the thickness of the top patch 140 may be the same as the bottom patch 120 . In some embodiments, the thickness of the bottom patch 120 may be thinner than the top patch 140 . The thinness of the bottom patch 120 may allow for greater flexibility and compliancy, so that the bottom patch 120 may be compressed and inserted through a tissue defect 110 . The thickness of the top patch 140 may be thicker than the bottom patch 120 , so that strength may be added to the multi-laminar repair matrix 100 . In some embodiments, the thickness of the patch 120 , 140 is between about 0.1 mm and 4 mm.
- a multi-laminar repair matrix may comprise patches 120 , 140 that are pre-adhered pre-operatively.
- the pre-adhered multi-laminar repair matrix may be implanted to a tissue defect 110 such that the area of adhesion 1010 between the two patches 120 , 140 is aligned with the tissue defect 110 , and the tissue surrounding the tissue defect 110 is disposed in between the un-adhered peripheral regions 840 of the patches 120 , 140 .
- the separation distance between the und-adhered peripheral regions 840 of the two patches 120 , 140 illustrated by the arrow 860 in FIG. 10 , may be designed to approximate the thickness of a tissue surrounding a tissue defect 110 .
- the patches 120 , 140 may be connected to each other with the central regions 850 connected and the peripheral regions 840 unconnected according to any suitable mechanism known in the art.
- the shape of the patches 140 , 120 match the shape of a tissue defect 110 .
- the patches 120 , 140 can have a shape that follows the perimeter of the tissue defect 110 .
- the patches 120 , 140 may be triangular, as illustrated in FIGS. 11 a - b.
- the patch 120 , 140 may define a triangle.
- the adhesives 830 can be made from any suitable materials, such as biologically derived adhesives (fibrin, fibronectin, collagen, etc.), synthetic adhesives (PEG/PEG hydrogels, acrylic solutions, cyanoacrylate solutions, 2-octyl cyanoacylate, epoxy solutions, etc.) electrostatic/surface forces (electric charge, charge buildup, etc.), mechanical adhesion (fiber structure, entanglement, etc.). Further, the adhesives 830 can be formed onto the patch 120 , 140 in any number of ways, such as chemical crosslinking, prolonged thermal processing, moderate mechanical entanglement, application of moderate adhesives, high-pressure physical lamination, or any other suitable method.
- the adhesives 830 may further be utilized to adhere two patches 120 , 140 together and thereby alter the strength of a patch 120 , 140 .
- two patches 120 , 140 adhered to each other via multiple restricting adhesion points provide rigidity and structure support.
- different parts of a patch may be designed to exhibit different strengths.
- two patches 120 , 140 may be adhered to each other at the center of the patches 120 , 140 . Accordingly, the overall flexibility and compliance of the patches 120 , 140 may be changed.
- the distal arms 1410 may be detached from the patch 120 .
- grips 1930 that were holding on to the patch 120 may be released.
- the control 1420 on the PDS 1200 may be released, causing the distal arms 1410 to return to an axial position and detach from the patch 120 .
- releasing the control 1420 also causes the distal arms 1410 to retract proximally, thereby detaching from the patch 120 .
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- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Public Health (AREA)
- Transplantation (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Chemical & Material Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Prostheses (AREA)
Abstract
A multi-laminar repair matrix for repairing a tissue defect may comprise a top patch and a bottom compliant patch. The bottom compliant patch may be compressed and sized to fit through a tissue defect, and expand to a substantially planar state after being implanted to the tissue defect. The top and/or bottom patch may include adhesives. A tool for implanting a patch to a tissue defect may include a shaft, a plurality of arms pivotally connected to the shaft, and a control. The control may be configured to radially expand the plurality of arms upon actuation of the control.
Description
- This application claims is a continuation of U.S. patent application Ser. No. 14/213,216 filed Mar. 14, 2014, and titled “BIOMEDICAL PATCH AND DELIVERY SYSTEM,” which claims priority from U.S. provisional patent application No. 61/798,224 filed Mar. 15, 2013. Each of the foregoing applications is hereby incorporated by reference in its entirety. Further, Patent Cooperation Treaty patent application number PCT/US2011/040691, filed Jun. 16, 2011 and titled “BIOMEDICAL PATCHES WITH ALIGNED FIBERS,” and claiming priority to U.S. provisional patent application No. 61/355712 filed Jun. 17, 2010, are both hereby incorporated by reference herein in their entirety.
- The embodiments disclosed herein are directed to biomedical patches for repairing tissue defects, such as dural defects, and delivery systems applicable to same.
- The human brain and spinal cord are surrounded by a system of three protective membranes known as the meninges: the pia mater, the arachnoid mater, and the dura mater. The meninges serve to maintain a layer of cerebrospinal fluid around the brain and spinal cord, protect the brain and spinal cord from trauma/abrasion, and support extra-cortical vasculature carrying blood to/from the brain. The dura mater is a thick fibrous membrane lining the inner surface of the skull and spinal column which forms a water-tight sac around the central nervous system and serves as the primary barrier between nervous tissue and the underlying bone. Given the critical role of the dura mater in maintaining a closed layer of cerebrospinal fluid around the brain and spinal cord, and in protecting cortical tissue from physical damage/irritation, the health, patency, and structure of the dura mater is essential to proper cortical functions.
- The dura mater may sustain insults, injuries, or defects by accident, trauma, disease, or through routine surgical procedures. During the course of standard neurosurgical procedures the dura mater is commonly incised, resected, removed, or disrupted and must be repaired intraoperatively. In a large percentage of neurosurgical procedures surgeons must access anatomical sites within the skull, brain, spinal cord, and spinal column requiring disruption of the native dura mater. In the case of minimally invasive neurosurgical procedures (e.g. burr hole, shunt placement, ablation, etc.), the dura mater may only be minimally incised (defect <1 cm2) to pass small tools into the underlying nervous tissue. In the case of more invasive neurosurgical procedures (e.g. decompressive craniotomy, tumor excision, trauma, etc.), the dura mater may be vastly resected or completely removed (defects >1000-1500 cm2) to allow for cortical decompression or removal of diseased tissues. In all cases, regardless of the size or location of the dural defect, the dura mater must be repaired intraopertatively in order to restore the protective covering of the brain and reestablish the continuous layer of cerebrospinal fluid around the central nervous system. To facilitate this repair surgeons employ a type of surgical membrane or patch known as a “dural substitute.”
- Dural substitutes may comprise any type of material utilized to repair or replace the dura mater and promote healing and/or regeneration of native dura, a process known as “neoduralization”. In all instances dural substitutes must cover the dural defect, enable a water-tight seal of dural defect, and provide a suitable scaffold for the ingrowth of native dural fibroblasts. As a result the majority of dural substitutes comprise a planar material which may be sutured into the native dura or passively draped over the dural defect to close the dural defect.
- In some embodiments, a repair matrix for repairing a tissue defect may comprise a compliant patch, wherein the compliant patch is configured to be compressed and sized to fit through the tissue defect when in a first state, and the compliant patch is configured to be substantially planar when in a second state. The compliant patch may comprise a first adhesive, the compliant patch may define an outer surface when in the first state, and the first adhesive may be located on the outer surface. The compliant patch may comprise electro-spun fibers. The compliant patch when in the second state may have a shape that follows a perimeter of the tissue defect. The shape of the compliant patch when in the second state may be square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral. The compliant patch may be configured to biodegrade after being implanted to the tissue defect. In some embodiments, the tissue defect is a dural defect.
- In some embodiments, the repair matrix for repairing a tissue defect may further comprise a second patch. The second patch may be complaint. The second patch may comprise a second adhesive. The second patch may comprise electro-spun nanofibers. The shape of the second patch may follow a perimeter of the tissue defect. The shape of the second patch may be square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral. The second patch may be configured to biodegrade after being implanted to the tissue defect.
- In some embodiments, a central region of the compliant patch may be adhered to a central region of the second patch via an adhesive. In some embodiments, the compliant patch and the second patch may be separated by a third layer disposed in between the compliant patch and the second patch, wherein the compliant patch is in the second state. The third layer may comprise an adhesive. The third layer may comprise the same material as the material of the compliant patch and/or the second patch. The size of the third layer may be smaller than the size of the compliant patch, and the size of the third layer may be smaller than a size of the second patch, thereby leaving a slot around a peripheral region of the compliant patch and the second patch.
- In some embodiments, a kit for repairing a tissue defect may comprise a sterile easily opened packet containing a plurality of patches configured to repair a tissue defect, wherein each patch is progressively larger and the plurality of patches has same shape, wherein a number and sizes of the patches are such that at least one of the plurality of patches is correctly sized to repair a particular known type of tissue defect for a range of expected patients. The shape of the patches may be square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral.
- In some embodiments, a tool for repairing a tissue defect may comprise a shaft; a plurality of arms pivotally connected to a distal end of the shaft; and a control operably connected to the plurality of arms, wherein the control is configured to radially expand the plurality of arms upon actuation of the control. The plurality of arms may be biased radially. The plurality of arms may be configured to receive a compliant patch in a compressed state, wherein the plurality of arms is configured to expand a compliant patch loaded onto the plurality of arms from the compressed state to a substantially planar state upon radial expansion of the plurality of arms. The compliant patch in the compressed state may be sized to fit through the tissue defect. The complaint patch when in the substantially planar state may have a square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral shape.
- In some embodiments, a tool for repairing a tissue defect may comprise a proximal shaft, wherein a distal end of the proximal shaft is configured to removably connect to a proximal end of a distal shaft that is pivotally connected to a plurality of arms, wherein the proximal shaft comprises a control configured to operably connect to the plurality of arms via the distal shaft, wherein the control is configured to radially expand the plurality of arms upon actuation of the control. The tool may further comprise a cartridge for use with the tool, wherein the cartridge comprises the distal shaft and a compliant patch in a compressed state loaded onto the plurality of arms pivotally connected to the distal shaft, wherein the plurality of arms is configured to expand the compliant patch from the compressed state to a substantially planar state upon radial expansion of the plurality of arms. The compliant patch when in the substantially planar state may have a square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral shape.
- In some embodiments, a kit for repairing a tissue defect may comprise a patch delivery system. The patch delivery system may comprise a shaft, a plurality of arms pivotally connected to a distal end of the shaft, and a control operably connected to the plurality of arms, wherein the control is configured to radially expand the plurality of arms upon actuation of the control. The plurality of arms may be biased radially. The tissue defect may be a dural defect. The kit may further comprise a patch having a square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral shape. The kit may further comprise a compliant patch in a compressed state loaded onto the plurality of arms, wherein the plurality of arms is configured to expand the compliant patch from the compressed state to a substantially planar state upon radial expansion of the plurality of arms. The compliant patch in the compressed state may be sized to fit through the tissue defect. The complaint patch when in the substantially planar state may have a square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral shape.
- In some embodiments, a kit for repairing a tissue defect may comprise a patch delivery system. The patch delivery system may comprise a proximal shaft, wherein a distal end of the proximal shaft is configured to removably connect to a proximal end of a distal shaft that is pivotally connected to a plurality of arms, wherein the proximal shaft comprises a control configured to operably connect to the plurality of arms via the distal shaft, wherein the control is configured to radially expand the plurality of arms upon actuation of the control. The kit may further comprise saline solution, sutures, gauze, a ruler, or any combination thereof. The kit may further comprise a patch having a square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral shape. The kit may further comprise a cartridge for use with the patch delivery system. The cartridge may comprise the distal shaft and a compliant patch in a compressed state loaded onto the plurality of arms pivotally connected to the distal shaft, wherein the plurality of arms is configured to expand the compliant patch from the compressed state to a substantially planar state upon radial expansion of the plurality of arms. The kit may further comprise the distal shaft. The kit may further comprise a compliant patch in a compressed state loaded onto the plurality of arms pivotally connected to the distal shaft, wherein the plurality of arms is configured to expand the compliant patch from the compressed state to a substantially planar state upon radial expansion of the plurality of arms. The compliant patch when in the substantially planar state may have a square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral shape.
-
FIG. 1 illustrates a multi-laminar repair matrix applied to a tissue defect according to one embodiment. -
FIG. 2a illustrates a top view of one embodiment of a patch. -
FIG. 2b illustrates a perspective view of one embodiment of a patch. -
FIG. 3 illustrates a compressed patch according to one embodiment. -
FIG. 4 illustrates a method of implanting a patch to a tissue defect according to one embodiment. -
FIG. 5 illustrates a method of implanting a patch to a tissue defect according to one embodiment. -
FIG. 6 illustrates a method of implanting a patch to a tissue defect according to one embodiment. -
FIG. 7 illustrates a method of implanting a patch to a tissue defect according to one embodiment. -
FIG. 8 illustrates an example of a multi-laminar repair matrix with adhesives according to one embodiment. -
FIG. 9 illustrates an example of a multi-laminar repair matrix with adhesives according to one embodiment. -
FIG. 10 illustrates two patches adhered together according to one embodiment. -
FIG. 11a illustrates a triangular patch with adhesives according to one embodiment. -
FIG. 11b illustrates a triangular patch with adhesives according to one embodiment. -
FIG. 12a illustrates a square patch with adhesives according to one embodiment. -
FIG. 12b illustrates a square patch with adhesives according to one embodiment. -
FIG. 13a illustrates a rectangular patch with adhesives according to one embodiment. -
FIG. 13b illustrates a rectangular patch with adhesives according to one embodiment. -
FIG. 14a illustrates a patch delivery system according to one embodiment. -
FIG. 14b illustrates a patch delivery system according to one embodiment. -
FIG. 15a illustrates a patch delivery system according to one embodiment. -
FIG. 15b illustrates a patch delivery system according to one embodiment. -
FIG. 16a illustrates a patch delivery system according to one embodiment. -
FIG. 16b illustrates a patch delivery system according to one embodiment. -
FIG. 17 illustrates a patch delivery system with a compressed patch loaded onto the patch delivery system according to one embodiment. -
FIG. 18 illustrates a patch delivery system with a planar patch loaded onto the patch delivery system according to one embodiment. -
FIG. 19a illustrates a mechanism by which a patch delivery system holds and releases a patch according to one embodiment. -
FIG. 19b illustrates a mechanism by which a patch delivery system holds and releases a patch according to one embodiment. -
FIG. 20a illustrates a mechanism by which a patch delivery system holds and releases a patch according to one embodiment. -
FIG. 20b illustrates a mechanism by which a patch delivery system holds and releases a patch according to one embodiment. -
FIG. 21a illustrates a mechanism by which a patch delivery system holds and releases a patch according to one embodiment. -
FIG. 21b illustrates a mechanism by which a patch delivery system holds and releases a patch according to one embodiment. -
FIG. 22 illustrates a method of implanting a patch to a tissue defect using a patch delivery system according to one embodiment. -
FIG. 23 illustrates a method of implanting a patch to a tissue defect using a patch delivery system according to one embodiment. -
FIG. 24 illustrates a method of implanting a patch to a tissue defect using a patch delivery system according to one embodiment. -
FIG. 25 illustrates a method of implanting a second patch to a tissue defect using a patch delivery system according to one embodiment. -
FIG. 26 illustrates a method of implanting a second patch to a tissue defect using a patch delivery system according to one embodiment. -
FIG. 27 illustrates a method of implanting a second patch to a tissue defect using a patch delivery system according to one embodiment. -
FIG. 28 illustrates a method of implanting a pre-adhered multi-laminar repair matrix to a tissue defect using a patch delivery system according to one embodiment. -
FIG. 29 illustrates a method of implanting a pre-adhered multi-laminar repair matrix to a tissue defect using a patch delivery system according to one embodiment. -
FIG. 30 illustrates a method of implanting a pre-adhered multi-laminar repair matrix to a tissue defect using a patch delivery system according to one embodiment. -
FIG. 31a illustrates a cartridge configured to attach to a patch delivery system according to one embodiment. -
FIG. 31b illustrates the contents of the cartridge ofFIG. 31a according to one embodiment. -
FIG. 32 illustrates a cartridge and patch delivery system detached from each other according to one embodiment. - Multiple types of synthetic dural substitutes are available for use in repairing dural defects created during routine neurosurgical procedures. Yet, despite the present availability of dural substitutes, a substantial need exists for new dural substitutes that are easier to handle, increasingly reliable and suturable, increasingly compliant, faster to implant, effectively seal leaks in the dura, promote improved patient outcomes, and eliminate injurious side effects and complications.
- Currently, defects in the dura mater are repaired by implanting a patch to the outer surface of the dura mater. The patch must be sutured or otherwise fixed to the tissue in order to prevent leaks of fluid such as cerebrospinal fluid (CSF) and migration of the patch. In addition, extra care must be taken for defects near the base of the skull where internal pressure is higher and leaks are more likely.
- While the embodiments disclosed herein are described with reference to the dura mater and dural defects, they may be used with any suitable biological tissue and tissue defects. For example, the embodiments disclosed herein may be used in neosurgery, reconstructive surgery, plastic surgery, general surgery, minimally invasive surgery, orthopedic surgery, gastroenterology, wound care, and the like. Further, as used herein, the term “patch” may include a dural substitute, graft, mesh, membrane, scaffold, matrix, substrate, or replacement for any suitable biological tissue.
- Because fluid inside the dura mater exerts an outward force, leaks would be more effectively prevented by implanting a patch to the inner surface of the dura mater. The need to suture and/or the small size of a dural defect, however, currently make it impractical to implant a patch to the inner surface.
- Accordingly, the embodiments disclosed herein provide systems and methods for repairing a defect in a tissue, such as a dural defect, by implanting a patch to the inner surface of the tissue. In addition, a second patch may be implanted to the outer surface of the tissue defect. Adhesives may be included on the patch according to some embodiments of the invention in order to secure the patch to the tissue. The patch with adhesives may be used to repair a tissue defect from the outer surface, inner surface, or both. In addition, the shape of the patch and/or adhesives may be customized to repair the particular tissue defect being repaired. The embodiments disclosed herein further provide a system for delivering a patch to a tissue defect and encouraging effective cellular ingrowth and repair of a tissue defect.
-
FIG. 1 illustrates a side cross-sectional view of amulti-laminar repair matrix 100 according to some embodiments of the invention.FIG. 1 illustrates atop patch 140 and abottom patch 120 implanted over atissue defect 110, such as a dural defect. Referring toFIG. 1 , thetop patch 140 is applied to theouter surface 150 of thetissue defect 110, thereby patching thetissue defect 110. Still referring toFIG. 1 , thebottom patch 120 is applied to theinner surface 130 of thetissue defect 130, thereby plugging thetissue defect 110. Some embodiments may comprise one or more layers of patches, both beneath and above thetissue defect 110. Referring toFIG. 1 ,patches tissue defect 110 such that theperipheral regions 840 of thepatches defect 110. Such a configuration may promote optimal closure of thedefect 110 from all sides and approximate the surrounding tissue. - The materials, mechanical properties, and/or biological properties of the
top patch 140 may be different from thebottom patch 120. In other embodiments, the materials, mechanical properties, and/or biological properties of thetop patch 140 may the same as thebottom patch 120. The material of thepatches - In addition, the size, shape and/or geometry of the
top patch 140 may be different from thebottom patch 120. In other embodiments, the size, shape and/or geometry of thetop patch 140 may be the same as thebottom patch 120. In some embodiments, thebottom patch 120 may be smaller than thetop patch 120. The small size of thebottom patch 120 may allow thebottom patch 120 to be inserted through thetissue defect 110. With the larger size of thetop patch 140, a larger portion of thepatch 140 may contact the tissue, thus promoting cellular ingrowth and sealing of thetissue defect 110. In addition, in order to prevent foreign body response, inflammatory response, and/or allergic response, the size of thetop patch 140 may be limited. For example, thepatch tissue defect 110 such that there is sufficient contact between the tissue and thepatch tissue defect 110, without causing a foreign body response, an inflammatory response, and/or an allergic response. Thus, in some embodiments, the size of thetop patch 140 may be optimized to promote cellular ingrowth and sealing while preventing foreign body response, inflammatory response, and/or allergic response. In some embodiments, the general shape of the top 140 and bottom 120 patches may be the same, although thepatches - Further, the thickness of the
top patch 140 may be different from thebottom patch 120. In other embodiments, the thickness of thetop patch 140 may be the same as thebottom patch 120. In some embodiments, the thickness of thebottom patch 120 may be thinner than thetop patch 140. The thinness of thebottom patch 120 may allow for greater flexibility and compliancy, so that thebottom patch 120 may be compressed and inserted through atissue defect 110. The thickness of thetop patch 140 may be thicker than thebottom patch 120, so that strength may be added to themulti-laminar repair matrix 100. In some embodiments, the thickness of thepatch patch tissue defect 110 may promote cellular adhesion and/or tissue ingrowth. Thus, cellular ingrowth may occur in thetissue defect 110. In addition, the other side of thepatch patch tissue defect 110 may disadvantageously cause thepatch -
FIG. 2a illustrates a top view of apatch 120 in a planar state andFIG. 2b illustrates a perspective view of apatch 120 in a planar state. WhileFIGS. 2a-2b illustrate acircular patch 120, thepatch 120 can be any shape, as further described herein.FIG. 3 illustrates apatch 120 in a compressed state. As illustrated inFIG. 3 , in some embodiments, thepatch 120 in a compressed state can resemble the canopy of a closed umbrella.FIGS. 4-6 illustrate a method of implanting abottom patch 120 to theinner surface 130 of atissue defect 110. In some embodiments, a method of implanting abottom patch 120 to theinner surface 130 of atissue defect 110 includes compressing thepatch 120 from a planar state to a compressed state. In some embodiments, apatch 120 is pre-packaged in a compressed state. Referring toFIG. 4 , thecompressed patch 120 is then inserted through atissue defect 110. In some embodiments, thebottom patch 120 may be implanted without drastic compression of thepatch 120. For example, thetissue defect 110 may be sized such that abottom patch 120 can be inserted through thetissue defect 110 without drastic compression of thepatch 120. Referring toFIGS. 5-6 , once thepatch 120 is below thetissue defect 110, it is expanded to a substantially planar state. The patch 122 may be positioned as necessary so that it completely covers thetissue defect 110. Further, thepatch 120 may be positioned to be flush against the tissue surrounding thedefect 110, promoting intimate contact and repair of thetissue defect 110. Referring toFIG. 7 , in some embodiments, atop patch 140 may also be implanted to the outer surface of thetissue defect 110. Further, in some embodiments, adhesives may be included on the top and/orbottom patch patches tissue defect 110 or to secure thepatches bottom patch 120 and/ortop patch 140 may be implanted using a patch delivery system, which is further described herein. - In some embodiments, the bottom patch 122 is compliant so that it may be compressed and sized to fit through a
tissue defect 110. In addition, abottom patch 120 that is compliant can conform to the curvature of the tissue surrounding thedefect 110, thereby forming a complete seal and minimizing the possibility of leaks. In some embodiments, apatch patches patch - Adhesives or adhesive properties may be included on or in the
top patch 140 and/orbottom patch 120 for adhering the patch to a tissue or another patch and aid in patching and/or plugging atissue defect 110. In some embodiments, the adhesives can be separate components from thepatch patch patch patch patch patch - The adhesives may be included on a
patch patch bottom patch 120 only, thetop patch 140 only, and/or both the top 140 andbottom patch 120. The adhesive may be deposited onto apatch 120, 140 (or integrated onto thepatch patch top patch 140 norbottom patch 120 includes adhesives. - In some embodiments, one side of a
patch patch patch patch patch patch patch patch - The adhesive can comprise more than 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or less of the patch area. According to some embodiments, the amount of adhesive covering a
patch patch patch patch -
FIGS. 8-9 illustrate side views of afirst patch 810 and asecond patch 820 with exemplary configurations of adhesives830. It will be appreciated that “first patch” and “second patch” are used for convenience to refer to amulti-laminar repair matrix 100 comprising atop patch 140 applied to the outer surface of atissue defect 110 and abottom patch 120 applied to the inner surface of thetissue defect 110, and that “first” or “second” does not necessarily refer to thetop patch 140 orbottom patch 120. Thus, “first” may refer to atop patch 140 and “second” may refer to abottom patch 120, or “first” may refer to abottom patch 120 and “second” may refer to atop patch 140. - Referring to
FIG. 8 , twopatches adhesive 830. Thus, when implanted, the peripheral regions840 of thepatches defect 110. Further, the adhesive 830 at thecentral region 850 of thefirst patch 810 may adhere through thetissue defect 110 to the adhesive 830 at thecentral region 850 of thesecond patch 820. - Referring to
FIG. 9 , thefirst patch 810 is covered by adhesive 830 and thesecond patch 820 does not include anyadhesives 830 according to some embodiments of the invention. Thepatches first patch 810 adheres to tissue and adhesive 830 at thecentral region 850 of thefirst patch 810 adheres through atissue defect 110 to thecentral region 850 of thesecond patch 820. - The adhesive 830 can promote faster healing time, improve quality repair of the
tissue defect 110, and improve patient outcomes. Adhesive 830 between the tissue andpatch patch patch top patch 140 and abottom patch 120 to each other over atissue defect 110 can promote secure closure of thetissue defect 110, a complete seal of the peripheral tissue, and cellular infiltration leading to regeneration of native tissue. Additionally,adhesives 830 securing apatch adhesives 830 securing apatch patch tissue defect 110, may prevent migration of thepatch - Although
FIGS. 8-9 illustrate adhesives on amulti-laminar system 100, adhesives may be used with a single-laminar system as well. In addition, in some embodiments, amulti-laminar system 100 does not include any adhesives. - Referring to
FIG. 10 , in some embodiments, twopatches central region 850 of the twopatches peripheral regions 840 of thepatches central region 850 of bothpatches adhesives 830 to adhere to each other, as illustrated inFIG. 10 . In other embodiments, thecentral region 850 of only onepatch central region 850 of theother patch patches adhesives 830 may have a radius of about 3 cm. Thus, in some embodiments, a multi-laminar repair matrix may comprisepatches tissue defect 110 such that the area of adhesion 1010 between the twopatches tissue defect 110, and the tissue surrounding thetissue defect 110 is disposed in between the un-adheredperipheral regions 840 of thepatches peripheral regions 840 of the twopatches arrow 860 inFIG. 10 , may be designed to approximate the thickness of a tissue surrounding atissue defect 110. Thepatches central regions 850 connected and theperipheral regions 840 unconnected according to any suitable mechanism known in the art. - In some embodiments, two
patches patches FIG. 10b , in some embodiments, instead of adhesive 830, an intermediate patch can be located in its place. Thus, in some embodiments, amulti-laminar repair matrix 100 may include three layers ofpatches patches patches - In some embodiments, the shape of the
patches patch multi-laminar repair matrix 100, thetop patch 140 and/orbottom patch 120 may have a shape that varies from the standard square geometry shape. In a single-laminar repair matrix comprising only onepatch tissue defect 110, thatsingle patch patch patch patch tissue defect 110. - For example, in some embodiments, the shape of the
patches tissue defect 110. For example, thepatches tissue defect 110. For example, for procedures leaving a triangular shapeddefect 110 in a tissue, thepatches 120, 140may be triangular, as illustrated inFIGS. 11a -b. Thus, thepatch patch patch patch patch patch patch - Additionally, as illustrated in
FIG. 11a , a hollow triangular shaped adhesive 830 may be included on theperipheral region 840 of the top 140 and/orbottom patch 120. Thus, the adhesive 830 may define a hollow triangle. Referring toFIG. 11b , thecentral region 850 of the top 140 and/orbottom patch 120 may also include a triangularshaped adhesive 830. Thus, the adhesive 830 may define a triangle. - In some embodiments, the
patch circular patch circular patch patch circular patch patch - In some embodiments, a
circular patch patch - In some embodiments, the shape of the
patch patch patch patch - In some embodiments, the shape of the
patch - In some embodiments, the shape of the
patch quadrilateral patch quadrilateral patch - In some embodiments, the
patch patch patch tissue defect 110. - In addition, adhesive 830 placed in a
central region 850 of apatch tissue defect 110. Further, adhesive 830 placed in aperipheral region 840 of apatch tissue defect 110. Thus, thepatches adhesives 830 may be square, rectangular, oval, etc.FIGS. 12a-b and 13a-b illustrate some exemplary shapes ofpatches -
FIGS. 12a-b illustratepatches tissue defects 110 having a square shape. Specifically, the shape of thepatches patch FIG. 12 a. In another embodiment, thepatch center 850 of thepatch FIG. 12b .FIGS. 13a-b illustrate patches customized for repairingtissue defects 110 having a rectangular shape. - In some embodiments, the shapes and sizes of the top 140 and bottom 120 patches may be different. In addition, the shapes and sizes of the adhesives 220 on the top 140 and bottom 120 patches may be different. For example, the
bottom patch 120 may be a relatively large circularshaped patch 120 for plugging atissue defect 110, and thetop patch 120 may be a relatively smaller circular shapedpatch 140 for suturing in to the tissue surrounding thetissue defect 110. Additionally, thepatches - Accordingly, the
multi-laminar repair matrix 100 and/or single laminar repair matrix and customized designs can provide superior outcomes post-operatively due to customization of the repair matrix to thetissue defect 110. In some embodiments, the repair matrix is pre-packaged and pre-customized by type oftissue defect 110. Thus, in some embodiments the repair matrix does not require significant shaping or customization for use in repairing atissue defect 110. The pre-customized packages can improve the intraoperative efficiency of surgeons. Instead of hand-cutting patches in the operating room to fit atissue defect 110, the surgeon can simply select the proper customized package for theappropriate tissue defect 110. In addition, the pre-customized repair matrix may have the benefits of more rapid deployment and implantation time, superior fit to thetissue defect 110, optimized mechanical properties pertaining to thetissue defect 110, and optimized biological properties pertaining to thetissue defect 110. - The adhesive 830 can promote faster healing time, improved quality repair of the
tissue defect 110, and improved patient outcomes. Adhesive 830 between the tissue andpatch top patch 140 and abottom patch 120 to each other over atissue defect 110 can promote secure closure of thetissue defect 110, a complete seal of the peripheral tissue, and cellular infiltration leading to regeneration of native tissue. Additionally,adhesives 830 securing apatch adhesives 830 securing apatch patch tissue defect 110 can prevent migration of the patch and dehiscence. - The
adhesives 830 can be made from any suitable materials, such as biologically derived adhesives (fibrin, fibronectin, collagen, etc.), synthetic adhesives (PEG/PEG hydrogels, acrylic solutions, cyanoacrylate solutions, 2-octyl cyanoacylate, epoxy solutions, etc.) electrostatic/surface forces (electric charge, charge buildup, etc.), mechanical adhesion (fiber structure, entanglement, etc.). Further, theadhesives 830 can be formed onto thepatch patch adhesives 830 may include fibrin and/or cyanoacrylate. Fibrin and cyanoacrylate are generally known to have good adhesion properties for biological tissues. In addition, fibrin may be a natural structural element of native tissue, thus allowing cells to more rapidly bind onto thepatch patch - In some embodiments,
adhesives 830 are included on apatch defect 110. Acompliant patch patch adhesives 830 may be placed anywhere throughout thepatch defect 110 and/or to anotherpatch tissue defect 110. In some embodiments, thebottom patch 120 and/ortop patch 140 is compliant.Compliant patches - The
top patch 140 may be secured by adhesives only, sutures only, both adhesives and sutures, or any fixation technique known in the art. Thus, thetop patch 140 may be secured by suturing, stapling, tacking, tucking, folding, pinning, crimping, sealing, tissue welding, gluing, fusing, adhesives, or any combination thereof. In some embodiments, thetop patch 140 is implanted according to “onlay” techniques known in the art. Thebottom patch 120 may be secured to thetissue defect 110 byadhesives 830 according to some embodiments of the invention. In some embodiments, thebottom patch 120 does not include adhesive 220, but thetop patch 140 includes adhesive 830 for adhering to thebottom patch 120. Some embodiments provide for amulti-laminar repair matrix 100 without anyadhesives 830, neither on thetop patch 140 nor thebottom patch 120. External force exerted by fluid, such as cerebrospinal fluid in the dura mater, can help keep thebottom patch 120 in place and plug atissue defect 110. Even without anyadhesives 830, themulti-laminar repair matrix 100 achieves a high quality seal due to the additional layer ofpatch tissue defect 110. - In some embodiments, the
adhesive elements 830 are used in a single-laminar patch system. For example,adhesives 830 may be included on theperipheral region 840 of abottom patch 120 for adhering to theinner surface 130 of the peripheral tissue surrounding adefect 110. In some embodiments, atop patch 140 is not implanted. In other embodiments, atop patch 140 is implanted to the outer surface of atissue defect 110 but abottom patch 120 is not implanted. Thetop patch 140 may includeadhesive elements 830 for adhering to the outer surface of thetissue defect 110. Theadhesives 830 andpatch multi-laminar repair matrix 100. - Some embodiments include a single-laminar patch, such as a
bottom patch 120, without anyadhesives 830. External force exerted by fluid, such as cerebrospinal fluid in the dura mater, can help keep thebottom patch 120 in place and plug atissue defect 110. - In some embodiments, the adhesive 830 may biodegrade and/or lose its adhesive properties after a certain amount of time. Some embodiments include a
resorbable patch patch tissue defect 110. In some embodiments, the timing of resorbtion of thepatch patch patch adhesives 830 adhering apatch tissue defect 110, the biodegrading time may be the same as thepatch adhesives 830 adhering twopatches tissue defect 110, the biodegrading time may be longer than thepatch patch patch patch patch patch adhesives 830 with different biodegrading times on different regions of thepatch - The
adhesives 830 may further be utilized to adhere twopatches patch patches patches patches patches - The bottom 120 and/or
top patch 140 may be deployed to a treatment site using thedelivery system 1400 illustrated inFIG. 14a .FIG. 14a illustrates a patch delivery system (“PDS”) 1400 with ashaft 1430,distal arms 1410, and acontrol 1420. ThePDS 1400 may be made from plastic and/or surgical grade metal such as titanium alloy or nitinol. In some embodiments of the invention, the distal end of theshaft 1430 branches off intodistal arms 1410 that are pivotally connected to theshaft 1430 at one or more connection points 1450. Thedistal arms 1410 provide a structural frame and support for holding apatch PDS 1400 may further include acontrol 1420 operably connected to thedistal arms 1410. In some embodiments, thecontrol 1420 is located toward the proximal end of theshaft 1430. Further, the length of theshaft 1430 may be variable. Thedistal arms 1410 may be made of nitinol, surgical grade stainless steel, or any other suitable material known in the art. In some embodiments, thedistal arms 1410 may be thin so that they are flexible. - In some embodiments, the
PDS 1400 includes ahandle 1440 at the proximal end of theshaft 1430 for interoperative handling of thePDS 1400. Thecontrol 1420 may be placed at or near thehandle 1440. The proximal end of theshaft 1430 may also include one or more Luer ports, check valve and similar components for infusion or aspiration of fluid and medicine. For example, the ports may allow the hydration of a patch prior to delivery. Such components are well known in the art. - The
control 1420 may operate thedistal arms 1410 by delivering a mechanical force or an electrical signal to thedistal arms 1410. In some embodiments, thePDS 1400 is battery powered and/or wireless. The mechanical force may include a linear force, a torque, a stress, a strain, or other mechanical force. The mechanical force may be applied by a user's hand or robotic control and may be applied to thecontrol 1420 on the PDS 1200. The electrical signal may include an electrical current, an electrical change in voltage, or other electrical signal. In some embodiments, the electrical signal controls thedistal arms 1410 through a motor or other mechanism. - Referring to
FIG. 14a , thedistal arms 1410 may be axially aligned with the axis of theshaft 1430 when thedistal arms 1410 are in a first position. Referring toFIG. 14b , when thedistal arms 1410 are in a second position, thedistal arms 1410 may expand radially from theshaft 1430. Multiple other methods of arm deployment are possible. Thedistal arms 1410 may be extended from an axial position to a radial position by actuating thecontrol 1420. Thecontrol 1420 may be a trigger, switch, button, knob or the like. Thecontrol 1420 may be configured to expand thedistal arms 1410 radially in any number of ways. Thecontrol 1420 further includes a mechanism for returning thedistal arms 1410 to an axial position, described herein as “releasing” thecontrol 1420. Thecontrol 1420 may be released by moving a switch, knob, trigger, actuator, controller, etc. to another position. In another embodiment, thecontrol 1420 includes two buttons, one for radially expanding thedistal arms 1410 and one for compressing thedistal arms 1410 to an axial position. Thecontrol 1420 may be released and actuated via any of the above and via any mechanism known in the art. - Referring to
FIG. 15a , in some embodiments, thedistal arms 1410 are contained within adistal tube 1510 attached to the distal end of theshaft 1430. Thedistal arms 1410 may be contained in an axial position when inside thedistal tube 1510 and biased radially so that when thedistal arms 1410 are positioned outside thedistal tube 1510, thedistal arms 1410 expand radially, as illustrated inFIG. 15b . Thedistal arms 1410 may be positioned outside thedistal tube 1510 by applying an axial distal force, as illustrated by thearrow 1520. Accordingly, in some embodiments, thecontrol 1420 may be operably connected to thedistal arms 1410 such that actuating thecontrol 1420 applies an axial distal force, causing thedistal arms 1410 to move axially and distally outside thedistal tube 1510. Thedistal arms 1410 may be radially biased, such that thedistal arms 1410 expand radially when moved outside thedistal tube 1510. Further, releasing thecontrol 1420 may cause thedistal arms 1410 to retract proximally, back inside thedistal tube 1510 and to an axial position. -
FIG. 16a-b illustrate another embodiment of radially expanding the distal arms 1210. Referring toFIG. 16a , aPDS 1400 may includelinkages 1610 connected to thedistal arms 1410 near the connection points 1450. Actuating thecontrol 1420 can cause thelinkages 1610 to move in the direction shown by thearrow 1620 , thereby radially expanding thedistal arms 1410. - In some embodiments, the
patch shaft 1430 when it is deployed to thetissue defect 110. Thepatch tissue defect 110 by bending theshaft 1430, which can be flexible. In some embodiments, it may be advantageous for thepatch shaft 1430 due to the angle of insertion or approach to the tissue defect location (e.g. hernia). -
FIG. 3 illustrates acompressed patch PDS 1400. As illustrated inFIG. 3 , in some embodiments, thepatch patch FIG. 3 , in some embodiments, acompressed patch compressed patch peak 310, anouter surface 320, and aninner surface 330. In some embodiments, thepeak 310 corresponds to thecentral region 850 of apatch patch PDS 1400 can comprise multiple layers that have been pre-adhered to each other pre-operatively. For example, twopatches -
FIG. 17 illustrates acompressed patch PDS 1400 according to some embodiments of the invention. Referring toFIG. 17 , the distal arms 1820 may be positioned over theouter surface 310 of acompressed patch FIG. 18 illustrates aPDS 1400 withdistal arms 1410 that are radially expanded. In addition,FIG. 18 illustrates apatch distal arms 1410.FIGS. 19a -b, 20 a-b, and 21 a-b, illustrate a close up view of the annotated portion of thePDS 1400 illustrated inFIG. 18 . Referring toFIGS. 18, 19 a-b, 20 a-b, and 21 a-b, in some embodiments, aPDS 1400 includesgrips 1930 toward the distal end of thedistal arms 1410. Thegrips 1930 may be clips, clamps, pincers, pinchers, grabbers, or the like, that secure thepatch distal arms 1410 by holding thepatch patch PDS 1400 may include a mechanism for controlling the release of thegrips 1930. The mechanism may further allow control of how tightly thegrips 1930 hold onto apatch -
FIGS. 19a -b, 20 a-b, and 21 a-b illustrates various mechanisms by which thegrips 1930 can hold and release apatch linkage 1910 can be coupled to agrip element 1930 through any suitable mechanism, such as mechanical or chemical.FIG. 19a illustrates twogrip elements 1930, with apatch grip elements 1930. As illustrated inFIG. 19b , moving onegrip element 1930 relative to the other can increase the space between thegrip elements 1930, thereby releasing thepatch grip element 1930 can be utilized to release thepatch arrow 1950, as illustrated inFIG. 19a . In some embodiments, actuating thecontrol 1420 on thePDS 1400 can move thelinkage 1910 and thereby release thepatch - Referring to
FIGS. 20a -b, twogrip elements 1930 can be pivotally connected at the distal tip of adistal arm 1410. Alinkage 1940 can be coupled to agrip element 1930. Referring toFIGS. 20a -b, moving thelinkage 1940 in the direction of thearrow 1950 can increase the angle between the twogrip elements 1930, thereby releasing thepatch - Referring to
FIG. 21a , alinkage 1940 can extend past thedistal arm 1410 and then curl underneath thepatch patch linkage 1940 forms acoil 2110. Thecoil 2110 can be disposed so that it is inserted through thepatch patch distal arms 1410 and thepatch FIGS. 21a -b, actuating thecontrol 1420 on thePDS 1400 can cause thelinkage 1940 to move in the direction of the arrow 2150, removing thecoil 2110 from thepatch patch distal arms 1410. -
FIGS. 22-24 illustrate aPDS 1400 in use to deliver and implant abottom patch 120 to the inner surface of atissue defect 110, thereby plugging thetissue defect 110. Referring toFIG. 22 , aPDS 1400 with a loadedbottom patch 120 is inserted through atissue defect 110, until the entire length of thedistal arms 1410 is distal (below) thetissue defect 110. Referring toFIGS. 23-24 , thecontrol 1420 on thePDS 1400 may be actuated, causing thedistal arms 1410 to expand radially, and thereby causing thebottom patch 120 to similarly expand, since thedistal arms 1410 are attached to thebottom patch 120 via any of the mechanisms described above (e.g., grips 1930 that hold the patch 120). Accordingly, thebottom patch 120 may be expanded on the side distal to thetissue defect 110. Thebottom patch 120 may be expanded from a compressed state to an expanded state that is substantially planar. Thepatch 120 may then be positioned laterally to ensure that theentire tissue defect 110 is plugged by thebottom patch 120. Thepatch 120 may also be moved in a proximal direction, bringing thepatch 120 in contact with theinner surface 130 of thetissue defect 110. - After the expanded
bottom patch 120 is brought to the desired position, thedistal arms 1410 may be detached from thepatch 120. For example, grips 1930 that were holding on to thepatch 120 may be released. In addition, thecontrol 1420 on the PDS 1200 may be released, causing thedistal arms 1410 to return to an axial position and detach from thepatch 120. In some embodiments, releasing thecontrol 1420 also causes thedistal arms 1410 to retract proximally, thereby detaching from thepatch 120. - After the
bottom patch 120 is implanted, atop patch 140 may also be implanted according to some embodiments of the invention. In some embodiments, only abottom patch 120 is implanted, and notop patch 120 is implanted. In other embodiments, only atop patch 140 is implanted. Atop patch 140 may be implanted to atissue defect 110 in a similar manner as thebottom patch 120. -
FIGS. 25-27 illustrate a method of implanting atop patch 140 to atissue defect 110. AlthoughFIGS. 25-27 depict abottom patch 120, it will be appreciated that the disclosed methods may also be used to implant atop patch 140 to atissue defect 110 without abottom patch 120. - Referring to
FIG. 25 , aPDS 1400 with a loaded compressedtop patch 140 is positioned over atissue defect 110. Referring toFIG. 26 , acontrol 1420 on thePDS 1400 may be actuated, causing thedistal arms 1410 to expand radially and thetop patch 140 to similarly expand. Next, thePDS 1400 may be used to move thetop patch 140 to a desired position. For example, thetop patch 140 may be positioned to contact the outer surface of atissue defect 110 and completely cover thetissue defect 110. Referring toFIG. 27 , thecontrol 1420 may be released, causing thedistal arms 1410 to return to an axial position and detach from thetop patch 140. - The
PDS 1400 may be used with any number of types ofpatches compliant patch PDS 1400. The compliant nature of thepatch patch distal arms 1410. In some embodiments, thepatch patch PDS 1400. Other examples ofpatches patch - In some embodiments, the
top patch 140 and/orbottom patch 120 contain shape memory, allowing thepatch distal arms 1410 on aPDS 1400 may help to expand thepatch distal arms 1410 may not be necessary for thepatch patch distal arms 1410 are used to expand apatch distal arms 1410 and cause thepatch -
FIGS. 28-30 illustrate a method of implanting a multi-laminar repair matrix that has been pre-adhered pre-operatively 2810, as described above with respect toFIG. 10 . The pre-adheredmulti-laminar repair matrix 2810 may comprise atop patch 140 and a bottom 120 adhered to each other at thecentral regions 850, and un-adhered at theperipheral regions 840, thus defining aslot 860 between the top 140 and bottom 120 patches. Referring toFIGS. 28-30 , the pre-adheredmulti-laminar repair matrix 2810 may be compressed and loaded onto thedistal arms 1410, then expanded to a planar state by actuating thecontrol 1420 on thePDS 1400. In some embodiments, the pre-adheredmulti-laminar matrix 2810 may be implanted such that theslots 860 receive the tissue surrounding thetissue defect 110 at substantially the same time. In some embodiments, the top and bottom portions of theslot 860 are flexible. - In some embodiments,
patches shaft 1430 and further may be pre-customized by type oftissue defect 110. Accordingly, the shape of thepatches tissue defect 110. For example, thepatches tissue defect 110. Thus, a physician may select aPDS 1400 with a pre-loaded andpre-customized patch tissue defect 110 that the physical will repair. -
FIG. 31a illustrates apre-loaded cartridge 3110 according to some embodiments of the invention.FIG. 31b illustrates the contents of thepre-loaded cartridge 3110 according to some embodiments. In some embodiments, thedistal arms 1410 are removably attached to theshaft 1430 of aPDS 1400. As illustrated inFIG. 31 b, thepre-loaded cartridge 3110 may include adistal shaft 3120 anddistal arms 1410 at the distal end of thedistal shaft 3120. Thedistal shaft 3120 may be detached from theproximal shaft 1430, as illustrated inFIG. 32 . Referring toFIG. 31 b, thepre-loaded cartridge 3110 may also include acompressed patch distal arms 1410, and alinkage 3130 at the proximal end of thedistal shaft 3120. In some embodiments, thedistal arms 1410 does not include a pre-loadedcompressed patch FIG. 32 illustrates one embodiment of aproximal shaft 1430 removed from thedistal shaft 3120. Referring toFIG. 32 , in some embodiments the proximal end of thedistal shaft 3120 may include alinkage 3130. In addition, the distal end of theproximal shaft 1430 may include alinkage 3210. Thepre-loaded cartridge 3110 may be connected to the distal end of theproximal shaft 1430 by connecting thelinkage 3210 in theproximal shaft 1430 to thelinkage 3130 in the distal shaft 312-. Thepre-loaded cartridge 3110 and theproximal shaft 1430 may also be connected according to any suitable mechanism known in the art. In some embodiments, theproximal shaft 1430 is re-usable and thepre-loaded cartridge 3110 and its components are disposable. Thepre-loaded cartridge 3110 may come in a variety of configurations, including those for different types, shapes, and sizes oftissue defects 110. - In some embodiments, a kit may be provided and customized for
certain tissue defects 110. The kit may advantageously include components such as aPDS 1400,reloadable cartridges 3110, amulti-laminar repair matrix 100, a single laminar repair matrix, saline, sutures, rulers, a gauze, any other surgical dressing, and the like. This kit may be contained in a sterile environment in containers well known in the art. For example, the containers may be plastic bags that are secured and easily opened. All the components inside the kit may be sterilized before being packaged in the container. - In some embodiments, the kit may include a
reloadable cartridge 3110 and aPDS 1400 detached from thedistal shaft 3120 anddistal arms 1410. Apatch distal arms 1410 packaged in thereloadable cartridge 3110. In other embodiments, apatch distal arms 1410 packaged in thereloadable cartridge 3110. Thepatch certain tissue defect 110 of a similar size and shape. In addition, the kit may include a selection ofseveral patches tissue defect 110 of a particular size and shape. For example, the kit may include a selection ofseveral patches tissue defects 110 of varying sizes. The triangular shapedpatches defects 110 in the posterior fossa, such as surgical repair of Chiari malformations. In addition, the triangular shaped patches may have a base with a length of about 0.5 cm and 10 cm, a height between about 1 cm and 20 cm, and angles at the vertices of the triangular shapedpatch several patches tissue defects 110 of varying shapes. In some embodiments, the kit may include aPDS 1400 attached to thedistal arms 1410. In other embodiments, the kit may include areloadable cartridge 3110 and noPDS 1400. Any combination of components may be included in the kit. In some embodiments, the components are customized for certain tissue defects. For example, as explained above, the shape, size, and configuration of thepatches adhesives 830 may be customized. - In some embodiments, the
PDS 1400 may be disposable after a single use. In other embodiments, thePDS 1400 may be re-usable. In some embodiments, thePDS 1400 is adapted to receive loadable cartridges containing patches. - Various modifications to the implementations described in this disclosure may be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the claims are not intended to be limited to the implementations shown herein, but are to be accorded the widest scope consistent with this disclosure, the principles and the novel features disclosed herein. Certain features that are described in this specification in the context of separate embodiments also can be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment also can be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.
- Similarly, while operations may be described as occurring in a particular order, this should not be understood as requiring that such operations be performed in the particular order described or in sequential order, or that all described operations be performed, to achieve desirable results. Further, other operations that are not disclosed can be incorporated in the processes that are described herein. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the disclosed operations. In certain circumstances, multitasking and parallel processing may be advantageous. Additionally, other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.
Claims (21)
1.-29. (canceled)
30. A repair matrix for repairing a tissue defect, the repair matrix comprising:
a top flexible patch, the top flexible patch comprising material that facilitates tissue growth;
a bottom flexible patch, the bottom flexible patch comprising material that facilitates tissue growth, wherein a periphery of the bottom flexible patch comprises an adhesive; and
a connecting portion connecting a non-peripheral portion of the top flexible patch with a non-peripheral portion of the bottom flexible patch, the connecting portion comprising a height adapted to prevent adhesion of the bottom flexible patch to the top flexible patch,
wherein the top flexible patch comprises a first biodegrade time, the bottom flexible patch comprises a second biodegrade time, and the adhesive comprises a third biodegrade time, wherein the third biodegrade time is longer than the first biodegrade time and the second biodegrade time.
31. The repair matrix of claim 1, wherein one or both of the top flexible patch and the bottom flexible patch comprises electro-spun fibers.
32. The repair matrix of claim 1, wherein one or both of the top flexible patch and the bottom flexible patch comprises wholly synthetic dural substitute material.
33. The repair matrix of claim 1, wherein one or both of the top flexible patch and the bottom flexible patch is configured to biodegrade after being implanted to tissue surrounding a tissue defect.
34. The repair matrix of claim 33 , wherein the tissue defect is a dural defect.
35. The repair matrix of claim 1, wherein a peripheral portion of the top flexible patch comprises an adhesive.
36. The repair matrix of claim 1, wherein a shape of the top flexible patch substantially matches a shape of the bottom flexible patch.
37. The repair matrix of claim 1, wherein a shape of the top flexible patch is different from a shape of the bottom flexible patch.
38. The repair matrix of claim 1, wherein one or both of the top flexible patch and the bottom flexible patch comprises shape memory material.
39. The repair matrix of claim 1, wherein the height of the connecting portion is adjustable to substantially match a width of tissue surrounding a tissue defect.
40. The repair matrix of claim 1, wherein the connecting portion connecting the non-peripheral portion of the top flexible patch with the non-peripheral portion of the bottom flexible patch comprises an adhesive.
41. The repair matrix of claim 1, wherein the connecting portion connecting the non-peripheral portion of the top flexible patch with the non-peripheral portion of the bottom flexible patch comprises a same material as the material of the top flexible patch and/or the bottom flexible patch.
42. A kit for repairing a dural defect, comprising:
a sterile packet containing a plurality of biodegradable patches, wherein the plurality of biodegradable patches comprise varying sizes, wherein each of the plurality of biodegradable patches comprises material that facilitates tissue growth, wherein a periphery of one or more of the plurality of biodegradable patches comprises an adhesive for adhering the biodegradable patch to a surface of tissue surrounding a tissue defect, and wherein the one or more of the plurality of biodegradable patches comprises a first biodegrade time, and the adhesive of the one or more of the plurality of biodegradable patches comprises a second biodegrade time, wherein the second biodegrade time is longer than the first biodegrade time.
43. The kit of claim 42 , wherein each of the plurality of biodegradable patches comprises a shape that is square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral.
44. The kit of claim 42 , wherein each of the plurality of biodegradable patches comprises shape memory material.
45. The kit of claim 42 , wherein each of the plurality of biodegradable patches comprises electro-spun fibers.
46. The kit of claim 42 , wherein each of the plurality of biodegradable patches comprises wholly synthetic dural substitute material.
47. A repair matrix for repairing a tissue defect, comprising:
a flexible patch, the flexible patch comprising a material formed by electrospinning that facilitates tissue growth, wherein the flexible patch in a first state is configured to be compressed to facilitate implantation of the flexible patch to tissue surrounding a tissue defect, and the flexible patch in a second state is configured to be expanded such that the flexible patch substantially conforms to a curvature of the tissue surrounding the tissue defect,
wherein a periphery of the flexible patch in the second state comprises an adhesive for adhering the flexible patch to the tissue surrounding the tissue defect,
wherein the flexible patch comprises a first biodegrade time, and the adhesive comprises a second biodegrade time, wherein the second biodegrade time is longer than the first biodegrade time.
48. The repair matrix of claim 47 , wherein the flexible patch is configured to biodegrade after being implanted to the tissue surrounding a tissue defect.
49. The repair matrix of claim 47 , wherein the flexible patch comprises wholly synthetic dural substitute material.
Priority Applications (1)
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US16/562,936 US20200060800A1 (en) | 2013-03-15 | 2019-09-06 | Biomedical patch and delivery system |
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US201361798224P | 2013-03-15 | 2013-03-15 | |
US14/213,216 US10441403B1 (en) | 2013-03-15 | 2014-03-14 | Biomedical patch and delivery system |
US16/562,936 US20200060800A1 (en) | 2013-03-15 | 2019-09-06 | Biomedical patch and delivery system |
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