US20230181339A1 - Systems and methods for sizing and introduction of soft-tissue allografts - Google Patents
Systems and methods for sizing and introduction of soft-tissue allografts Download PDFInfo
- Publication number
- US20230181339A1 US20230181339A1 US18/078,579 US202218078579A US2023181339A1 US 20230181339 A1 US20230181339 A1 US 20230181339A1 US 202218078579 A US202218078579 A US 202218078579A US 2023181339 A1 US2023181339 A1 US 2023181339A1
- Authority
- US
- United States
- Prior art keywords
- suture
- space
- bone
- allograft
- trial
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Classifications
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4657—Measuring instruments used for implanting artificial joints
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- 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
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/362—Skin, e.g. dermal papillae
-
- 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
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/3645—Connective tissue
- A61L27/365—Bones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0482—Needle or suture guides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/062—Measuring instruments not otherwise provided for penetration depth
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/063—Measuring instruments not otherwise provided for for measuring volume
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/3008—Properties of materials and coating materials radio-opaque, e.g. radio-opaque markers
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30721—Accessories
- A61F2002/30754—Implants for interposition between two natural articular surfaces
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
- A61F2/4241—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers
- A61F2002/4256—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers for carpo-metacarpal joints, i.e. CMC joints
- A61F2002/4258—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers for carpo-metacarpal joints, i.e. CMC joints for trapezo-metacarpal joints of thumbs
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2002/4615—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spacers
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4657—Measuring instruments used for implanting artificial joints
- A61F2002/4658—Measuring instruments used for implanting artificial joints for measuring dimensions, e.g. length
Definitions
- FIG. 5 B shows an isometric view of the apparatus of FIG. 6 A , with a portion of the tip of the trial sizer extending past the distal end of the delivery cannula.
- FIG. 11 A shows a top view of the thumb metacarpal bone, carpometacarpal joint, trapezium, and carpal bones of the hand.
- FIG. 12 A shows a top view of the hand bones with the trial sizer of FIG. 8 oriented where the peripheral surface of the head of the trial sizer faces bone.
- a set of two of the first suture passages 920 b and a corresponding set of two of the second suture passages 928 b is arranged relative to a reference plane (B-B) that extends parallel to the first and second slots 936 , 940 , and through the first and second sides 908 , 912 , of the body 904 , such that the set of two of the first suture passages 920 b are disposed on opposite sides of the plane, and the corresponding set of two of the second suture passages 928 b are disposed on opposite sides of the plane (B-B).
- the kit further comprises a package within which the other components of the kit are sealed.
Abstract
The present disclosure includes systems, methods, kits, and individual tools (e.g., trial sizers and delivery devices) for medical procedures involving a soft-tissue allograft for the correction of skeletal impairments (e.g., misalignments, arthritis, etc.).
Description
- This application is a continuation of U.S. patent application Ser. No. 16/449,022, filed Jun. 21, 2019, which claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 62/687,901, filed Jun. 21, 2018, each of which is hereby incorporated by reference in its entirety.
- The present application relates generally to systems and methods for a medical procedure involving soft-tissue allografts (e.g., dermal allograft) for the correction of skeletal impairment (e.g., misalignment, arthritis, etc.), and more particularly, but not by way of limitation, to sizers and delivery devices for introduction of such allografts.
- Examples of sizers and delivery devices that can be used for introduction of tissue implants are disclosed in U.S. Pat. No. 6,168,631 (the '631 Patent). Another example of an implant assembly is disclosed in U.S. Pat. No. 8,092,547 (the '547 Patent). An example of an implant for correction of skeletal misalignment is disclosed in U.S. Pat. No. 4,450,591 (the '591 Patent). Another example of a tissue implant is disclosed in U.S. Patent Application No. 2017/0189197 (the '197 Publication).
- One example of a skeletal impairment condition is a fallen arch or “flatfoot.” The condition involves a deformity in which the arches of the foot collapse, resulting in the entire sole of the foot being in complete or nearly complete contact with the ground. This may eventually cause other biomechanical issues with the physiology of the foot that, in turn, may adversely affect other parts of the body. The “flatfoot” condition occurs when the head of the talus bone is displaced medially and distally from the navicular bone, which in turn causes lateral misalignment throughout the foot as the talus and navicular bones tend to move outward. Furthermore, there is a change in relative alignment in the subtalar joint that occurs at the meeting point between the talus bone and the calcaneus bone such that the canal, which should naturally occur between the talus and calcaneus bones, is depressed. This canal is commonly referred to as the sinus tarsi. The misalignment of the talus and calcaneus bones eventually leads to misalignment of other bones in the foot and leg.
- Another example of a skeletal impairment condition is osteoarthritis of the carpometacarpal (CMC) joint. The CMC joint is where the saddle-shaped trapezium bone articulates with the first metacarpal bone. An osteoarthritic CMC joint can become painful enough to severely limit activities of daily life for a large portion of the population. While symptoms may be treated with physical therapy, rest and stabilization, or anti-inflammatory medications, surgical intervention may be clinically indicated if pain persists. Interpositional arthroplasty of the CMC joint is the most common surgical procedure to treat osteoarthritis of the CMC joint.
- Surgical intervention to treat osteoarthritis of the CMC joint begins with removal of a portion or all of the trapezium bone to create a void. To prevent complete collapse of the first metacarpal bone into the void created, a wire pin is used as a temporary stabilizer to align the base of the first metacarpal bone with the base of the index metacarpal. The flexor carpi radialis (FCP) tendon is then harvested, rolled up and sutured to prevent unrolling, and is interposed between the base of the thumb metacarpal and the scaphoid, the space previously occupied by the trapezium bone. In some cases, an additional procedure called a suspensionplasty is performed, where another piece of tendon is used to tie the base of the thumb metacarpal to the base of the index metacarpal.
- While the outcomes of interpositional arthroplasty of the CMC joint are acceptable, there are several disadvantages to the procedure, such as additional trauma to the patient in taking an autograft, morbidity associated with the graft donor site, and inadequate amount or inadequate quality of tendon available. The time it takes to harvest an FCP tendon graft is not insignificant, and can be increased even more if suspensionplasty is added as an additional procedure. Additionally, there is evidence that during healing, the tendon graft weakens and loses structural strength, necessitating the use of pins to help hold the thumb metacarpal in the right position while dense scar tissue forms to support the metacarpal.
- Prosthetic material, such as silicone rubber, has also been used to treat osteoarthritic CMC joints. However, all of these silicone rubber devices are subject to dislocation, fracture, abrasion and fatigue, which leads to the generation of small silicone particulate debris that cause a chronic inflammatory reaction called “silicone synovitis.”
- To address subtalar joint impairments, it has been discovered that by re-establishing the relative alignment between the talus and calcaneus bones, the overall arch structure of the foot can be reestablished as well. While this can be demonstrated by physically manipulating a person's foot, such physical manipulation is impractical during normal use of one's foot. As such, there have been various efforts made to provide implants which operate to physically reposition and realign the talus and calcaneus bones. However, like other prior art systems, apparatuses, and methods for sizing and introducing implants to correct skeletal impairments, the systems, apparatuses, and methods disclosed in the '631 Patent, the '547 Patent, the '591 Patent, and '197 Publication, make it exceedingly difficult to simplify the surgical procedure for delivering a tissue implant and maintaining natural motion of the bones after correcting the impairment. Hence, there is a need for a system and method for overcoming one or more of the above identified challenges.
- This disclosure includes configurations of devices, apparatuses, kits, and methods for sizing and introducing soft-tissue allografts for treatment or correction of skeletal impairments. Non-limiting examples of surgical procedures that benefit from the present disclosure include, but are not limited to: subtalar joint arthroplasty; carpometacarpal joint arthroplasty; lateral mid-foot interpositional arthroplasty (e.g., 4th/5th metatarsal-cuboid joint); ankle interpositional arthroplasty (e.g., tibio-talar joint); elbow interpositional arthroplasty (e.g., radio-capitellar joint); proximal femoral interpositional arthroplasty; and interphalangeal interpositional arthroplasty (e.g., proximal interphalangeal joints of the fingers). For example, at least some of the present configurations include a trial sizer comprising an elongated shaft having a proximal end and a distal end, and a radiopaque tip coupled to the distal end of the elongated shaft, the tip having a transverse dimension equal to or greater than a corresponding transverse dimension of the elongated shaft, and having dimensions that mimic the dimensions of a corresponding soft-tissue allograft. In this way, at least some configurations of the present apparatuses can aid in determining the appropriate size and location of the soft-tissue allograft appropriate for transplantation at the site of delivery in a way that has previously not been possible with prior art trial sizers.
- Some configurations of the present trial sizers comprise: an elongated shaft having a proximal end and a distal end; and a radiopaque tip coupled to the distal end of the elongated shaft, the tip having a transverse dimension equal to or greater than a corresponding transverse dimension of the elongated shaft, and having dimensions that mimic the dimensions of a corresponding soft-tissue allograft.
- In some configurations of the present trial sizers, the elongated shaft defines a channel extending between and through the proximal and distal ends of the elongated shaft. In some configurations of the present trial sizers, the elongated shaft is configured to indicate insertion depth. In some configurations of the present trial sizers, the distal end of the elongated shaft comprises a plurality of indicia to indicate insertion depth. In some configurations of the present trial sizers, the distal end of the elongated shaft defines one or more threads along a portion of a length of the distal end.
- In some configurations of the present trial sizers, the trial sizer further includes a trial sizer head defining a channel extending between, and through, a proximal end to a distal end, the trial sizer head being coupled to the proximal end of the elongated shaft. In some configurations of the present trial sizers, the trial sizer head is unitary with the elongated shaft.
- In some configurations of the present trial sizers, the radiopaque tip can be uncoupled from the distal end of the elongated shaft and the elongated shaft can be used to push an implant through the delivery cannula to an insertion point. In some configurations of the present trial sizers, the length of the radiopaque tip is from 8 mm to 25 mm.
- Some configurations of the present kits comprise: a configuration of the present trial sizers, and a delivery cannula comprising: an elongated body having a proximal end and a distal end, and defining a longitudinal channel extending between and through the proximal and distal ends; and a handle portion coupled to the proximal end of the elongated body, the handle portion defining a channel that is aligned with the longitudinal channel of the elongated body.
- In some configurations of the present kits, the elongated shaft defines a channel extending between and through the proximal and distal ends of the elongated shaft. In some configurations of the present kits, the elongated shaft is configured to indicate insertion depth. In some configurations of the present kits, the distal end of the elongated shaft comprises a plurality of indicia to indicate insertion depth. In some configurations of the present kits, the elongated shaft defines one or more threads along a portion of its length closer to the distal end than to the proximal end.
- In some configurations of the present kits, the kit further comprises a trial sizer head defining a channel extending between, and through, a proximal end to a distal end, the trial sizer head being coupled to the proximal end of the elongated shaft. In some configurations of the present kits, the trial sizer head is unitary with the elongated shaft of the trial sizer.
- In some configurations of the present kits, the radiopaque tip can be uncoupled from the distal end of the elongated shaft and the elongated shaft can be used to push an implant through the delivery cannula to an insertion point. In some configurations of the present kits, the length of the radiopaque tip is from 8 mm to 25 mm.
- In some configurations of the present kits, the elongated body of the delivery cannula comprises transparent material.
- In some configurations of the present kits, the kit further comprises a delivery tool comprising an elongated shaft having a proximal end and a distal end that is configured to indicate insertion depth. In some configurations of the present kits, the distal end of the elongated shaft comprises a plurality of indicia to indicate insertion depth. In some configurations of the present kits, the elongated shaft of the delivery tool has a diameter from 5 mm to 15 mm. In some configurations of the present kits, the delivery tool further comprises a delivery tool head coupled to the proximal end of the elongated shaft. In some configurations of the present kits, the delivery tool head is unitary with the elongated shaft.
- In some configurations of the present kits, the elongated shaft of the trial sizer is configured to have an outer diameter from 5 mm to 15 mm. In some configurations of the present kits, the delivery cannula is configured to have an inner diameter from 5 mm to 15 mm.
- In some configurations of the present kits, a distal end of the trial sizer head has a first portion with a first transverse dimension, and a second portion with a second transverse dimension larger than the first transverse dimension, the first transverse dimension being larger than a corresponding transverse dimension of the channel of the delivery cannula to prevent the first portion from entering the channel of the delivery cannula.
- In some configurations of the present kits, the kit further comprises at least one sterile dermal allograft having a diameter about equal to an average width of a canal between a subject's misaligned bones, where the dermal allograft implant is compressible and flexible. In some configurations of the present kits, the dermal allograft has a density sufficient to resist full compression of the canal.
- In some configurations of the present kits, the kit further comprises a package within which the other components of the kit are sealed.
- Some implementations of the present methods for sizing and delivering an implant comprise (a) disposing a delivery cannula through an incision in the skin of a patient such that a distal end of the delivery cannula is disposed between the incision and a given space between bones of the patient; (b) inserting a trial sizer of any of the presently disclosed kits or of the presently disclosed apparatuses into the space; (c) determining whether the trial sizer fits into the space in an acceptable way, and: (i) if the trial sizer fits into the space in an acceptable way, delivering an implant through the delivery cannula into the space; or (ii) if the trial sizer does not fit into the space in an acceptable way, sequentially repeating steps (b) and (c) with a trial sizer of a different size until a trial sizer fits into the space in an acceptable way.
- Some implementations of the present methods for sizing and delivering an implant further comprise removing the delivery cannula after delivering the implant. In some implementations of the present methods for sizing and delivering an implant, the method further comprises suturing the incision closed.
- In some implementations of the present methods for sizing and delivering an implant, the delivery cannula comprises an elongated body having a proximal end and a distal end, and defining a longitudinal channel extending between, and through, the proximal end and the distal end, and a handle portion coupled to the proximal end of the elongated body, the handle portion defining a channel that is aligned with and in fluid communication with the longitudinal channel of the elongated body.
- In some implementations of the present methods for sizing and delivering a soft-tissue allograft, the method further comprises inserting a delivery tool comprising an elongated shaft having a proximal end and a distal end, where the distal end of the elongated shaft is configured to indicate insertion depth.
- In some configurations of the present trial sizers, a trial sizer comprises: a cylindrical head having a first side, a second side, and a peripheral surface extending between the first and second sides and defining a circular cross sectional shape of the head; a handle having a proximal end and a distal end coupled to the peripheral surface; and where the head has dimensions that mimic the dimensions of a corresponding implant.
- In some configurations of the present trial sizers, the head is radiopaque. In some configurations, the head is unitary with the handle. In some configurations, a transverse dimension of the head is from 5 mm to 25 mm.
- In some configurations of the present suture delivery guides, a suture delivery guide comprises: a body having a first side and a second side and defining an implant chamber extending through the first side toward the second side, the body defining a plurality of first suture passages on a first side of the implant chamber and a plurality of second suture passages on a second side of the implant chamber, each of the second suture passages being aligned with a corresponding one of the first suture passages, the body further defining a first slot extending through the first side of the body and in fluid communication with all of the first suture passages, and a second slot extending through the first side of the body and in fluid communication with all of the second suture passages.
- In some configurations of the present suture delivery guides, the body has a medial portion defining the implant chamber and two lateral portions on opposite sides of the medial portion, a first one of the lateral portions defining the first suture passages, and a second one of the lateral portions defining the second suture passages.
- In some configurations of the present suture delivery guides, each of two of the first suture passages and a corresponding each of two of the second suture passages is intersected by a reference plane that extends parallel to the first and second slots and through the first and second sides of the body.
- In some configurations of the present suture delivery guides, a set of two of the first suture passages and a corresponding set of two of the second suture passages is arranged relative to a reference plane that extends parallel to the first and second slots and through the first and second sides of the body, such that the two first suture passages are disposed on opposite sides of the plane, and the two second suture passages are disposed on opposite sides of the plane.
- In some configurations of the present kits, a kit comprises: at least one of a configuration of any of the presently disclosed trial sizers; and at least one of a configuration of any of the presently disclosed suture delivery guides.
- In some configurations of the present kits, the kit further comprises: at least one sterile dermal allograft having a diameter about equal to an average width of a canal between a subject's misaligned bones, where the dermal allograft is compressible and flexible.
- In some configurations of the present kits, the dermal allograft has a density sufficient to resist full compression.
- In some configurations of the present kits, the kit further comprises a package within which the other components of the kit are sealed.
- In some implementations of the present methods, a method comprises: (a) inserting a trial sizer of any of the kits presently disclosed or any configuration of the trial sizers disclosed herein into a given space between bones of the patient; (b) determining whether the trial sizer fits into the space in an acceptable way, and (i) if the trial sizer fits into the space in an acceptable way, delivering an implant to the space; or (ii) if the trial sizer does not fit into the space in an acceptable way, sequentially repeating steps (b) and (c) with a trial sizer of a different size until a trial sizer fits into the space in an acceptable way.
- In some implementations of the present methods, a bone (e.g., the trapezium bone) is excised prior to inserting the trial sizer.
- In some implementations of the present methods, the peripheral surface of the head of the trial sizer faces bone.
- In some implementations of the present methods, the first end and the second end of the head of the trial sizer faces bone.
- In some implementations of the present methods, delivering an implant to the space comprises using a suture delivery guide. The suture delivery guide may include any configuration of the suture delivery guides presently disclosed.
- In some implementations of the present methods, delivering a soft-tissue allograft to the space comprises: inserting a suture anchor in the distal aspect of the 2nd metacarpal bone; and fastening a soft-tissue allograft to the suture anchor.
- In some implementations of the present methods, delivering a soft-tissue allograft to the space comprises: (a) passing a suture through a soft-tissue allograft and looping the suture through a flexor carpi radialis tendon; (b) looping the suture back through the soft-tissue allograft; (c) delivering the soft-tissue allograft over the suture and into the space between bones of the patient; and (d) tying the suture using an acceptable surgical knot.
- In some implementations of the present methods, a method comprises: providing at least one sterile pre-formed soft-tissue allograft rod plug having a diameter about equal to an average width of a space between a person's bones and a density sufficient to resist full compression of the space, the pre-formed soft-tissue allograft rod plug being resiliently compressible and flexible while remaining substantially as the formed plug; and delivering the at least one sterile pre-formed soft-tissue allograft rod plug into the space between a set of bones of the patient, where the set of bones is selected from the group of sets of bones consisting of: (a) a 1st metacarpal bone and a scaphoid bone; (b) a 4th metatarsal bone, 5th metatarsal bone, and cuboid bone; (c) a 5th metatarsal bone; (d) a tibia bone and a talus bone; (e) a radius bone and a humerus bone; (f) a femur bone and a pelvis bone; (g) any of the proximal phalanges of a hand and any of the corresponding intermediate phalanges of a hand.
- In some implementations of the present methods, a portion or all of a patient's trapezium bone is removed prior to delivering the at least one sterile dermal allograft.
- In some implementations of the present methods, a trial sizer is inserted into the space created between the 1st metacarpal and the scaphoid bone of the patient's hand prior to delivering the at least one sterile dermal allograft.
- In some implementations of the present methods, the space is between the 4th and 5th metatarsal bones of the foot and the cuboid bone of the foot.
- In some implementations of the present methods, the space is between a tibia bone and a talus bone of the patient.
- In some implementations of the present methods, the space is between a radius bone and a capitellum portion of a humerus bone of the patient.
- In some implementations of the present methods, the space is between a femur bone and a pelvis bone of the patient.
- In some implementations of the present methods, the space is between any of the proximal phalanges of a hand and any of the corresponding intermediate phalanges of a hand.
- The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are “coupled” may be unitary with each other. The terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise. The term “substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. In any configuration or implementation of the present devices, apparatuses, kits, and methods, the term “substantially” may be substituted with “within [a percentage] of” what is specified, where the percentage includes 0.1, 1, 5, and/or 10 percent.
- The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, an apparatus or kit that “comprises,” “has,” “includes” or “contains” one or more elements possesses those one or more elements, but is not limited to possessing only those elements. Likewise, a method that “comprises,” “has,” “includes” or “contains” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.
- Further, an apparatus, device, or structure that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.
- Any configuration or implementation of any of the present devices, apparatuses, kits, and methods can consist of or consist essentially of—rather than comprise/include/contain/have—any of the described steps, elements, and/or features. Thus, in any of the claims, the term “consisting of” or “consisting essentially of” can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb.
- Details associated with the configurations described above and others are presented below.
- The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers. The figures are drawn to scale (unless otherwise noted), meaning the sizes of the depicted elements are accurate relative to each other for at least the configurations depicted in the figures.
-
FIG. 1A shows a side view of a configuration of the present trial sizers. -
FIG. 1B shows a cross-sectional side view of the trial sizer ofFIG. 1A taken along a plane bisecting the elongated shaft extending from the trial sizer head to the tip. -
FIG. 1C shows an isometric view of the trial sizer ofFIGS. 1A, 1B . -
FIG. 1D shows a side view of the trial sizer ofFIGS. 1A-1C inserted into an incision in skin to an insertion point located 25 mm below the skin surface. -
FIG. 1E shows a side view of a trial sizer with an extended depth range. -
FIG. 2A shows a cross-sectional side view of a configuration of the delivery cannula of the present kits taken along a plane bisecting the elongated body extending from the proximal end to the distal end of the delivery cannula. -
FIG. 2B shows a side view of the delivery cannula ofFIG. 2A . -
FIG. 2C shows an isometric view of the delivery cannula ofFIGS. 2A-2B . -
FIG. 3A shows a side view of a configuration of the delivery tool of the present kits. -
FIG. 3B shows a cross-sectional side view of the delivery tool ofFIG. 3A taken along a plane bisecting the elongated shaft extending from the delivery tool head to the distal end of the delivery tool. -
FIG. 3C shows an isometric view of the delivery tool ofFIGS. 3A-3B . -
FIG. 4 shows a top view of a configuration of the present kits containing various sizes of trial sizers, delivery cannulas, and delivery tools, where the trial sizers and delivery tools are separately packaged within the sterile kit. -
FIG. 5A shows a cross-sectional view of a configuration of the present trial sizers inserted into a configuration of the present delivery cannula, with the tip of the trial sizer extending past the distal end of the delivery cannula at least 10 mm beneath the skin surface. -
FIG. 5B shows an isometric view of the apparatus ofFIG. 6A , with a portion of the tip of the trial sizer extending past the distal end of the delivery cannula. -
FIG. 6 shows a flow chart for depicting a process for sizing and delivering a tissue implant using a configuration of a trial sizer of any of the presently disclosed kits or presently disclosed apparatuses. -
FIG. 7A shows a cross-sectional view of the delivery cannula, inserted to a point at least 10 mm beneath the skin surface, with a dermal allograft implant at the distal end of the elongated shaft of the trial sizer that is inserted in the channel of the delivery cannula. -
FIG. 7B shows an isometric view ofFIG. 7A . -
FIG. 7C shows a cross-sectional view of the apparatus ofFIG. 7A , with the trial sizer pushing the dermal allograft implant beyond the distal end of the delivery cannula inserted beneath the skin surface. -
FIG. 7D shows a side view of the apparatus ofFIG. 7C , depicting the trial sizer pushing the dermal allograft implant to a depth of 25 mm beneath the skin surface. -
FIG. 7E shows an isometric view of the apparatus ofFIGS. 7C-7D . -
FIGS. 7F-7P shows top and isometric views of a patient's foot during a subtalar operation for sizing and delivering a tissue implant using an apparatus of the present invention. -
FIG. 8A shows an isometric view of another configuration of the present trial sizers. -
FIG. 8B-8D shows an isometric, side, and cross-sectional view of a head of the trial sizer ofFIG. 8A . -
FIG. 9A shows a side view of a configuration of the present suture delivery guides. -
FIG. 9B shows a top view of the suture delivery guide ofFIG. 9A . -
FIG. 9C shows a cross-sectional view of the suture passages disposed within the suture delivery guide ofFIG. 9A and taken along a plane bisecting the suture delivery guide. -
FIG. 9D shows a cross-sectional side view of the suture delivery guide ofFIG. 9A taken along a plane bisecting the longitudinal dimension of the suture delivery guide. -
FIG. 9E shows a cross-sectional top view of the suture delivery guide ofFIG. 9D . -
FIG. 9F shows a cross-sectional view of the suture passages on a side of the allograft chamber and taken along a plane bisecting the suture delivery guide. -
FIG. 9G shows a cross-sectional side view of a second configuration of the suture delivery guide taken along a plane bisecting the longitudinal dimension of the suture delivery guide. -
FIG. 9H shows a top view of the suture delivery guide ofFIG. 9G . -
FIG. 9I shows a cross-sectional view of the suture passages on a side of the allograft chamber and taken along a plane bisecting the suture delivery guide ofFIG. 9G . -
FIG. 10A shows a side view of the suture delivery guide ofFIGS. 9A-9F with a suture looping through an allograft and back within the implant chamber. -
FIG. 10B shows a top view of the suture delivery guide ofFIG. 10A . -
FIG. 11A shows a top view of the thumb metacarpal bone, carpometacarpal joint, trapezium, and carpal bones of the hand. -
FIG. 11B shows a sagittal view of the hand bones ofFIG. 11A . -
FIG. 11C shows an isometric view of the hand bones ofFIG. 11A . -
FIG. 12A shows a top view of the hand bones with the trial sizer ofFIG. 8 oriented where the peripheral surface of the head of the trial sizer faces bone. -
FIG. 12B shows a sagittal view ofFIG. 12A . -
FIG. 12C shows an isometric view ofFIG. 12A . -
FIG. 13A shows a top view of the hand bones with the trial sizer ofFIG. 8 oriented where the first and second sides of the head of the trial sizer face bone. -
FIG. 13B shows a sagittal view ofFIG. 13A . -
FIG. 13C shows an isometric view ofFIG. 13A . -
FIG. 14A shows a top view of the hand bones with an allograft disposed in a first orientation similar to the orientation of the trial sizer inFIG. 12A . -
FIG. 14B shows a sagittal view ofFIG. 14A . -
FIG. 14C shows an isometric view ofFIG. 14A . -
FIG. 15A shows a top view of the hand bones with an allograft disposed in a second orientation similar to the orientation of the trial sizer inFIG. 13A . -
FIG. 15B shows a sagittal view ofFIG. 15A . -
FIG. 15C shows an isometric view ofFIG. 15A . - Referring now to the drawings, and more particularly to
FIGS. 1A-7E ,FIG. 1A shows a side view of a configuration of the present trial sizers;FIG. 1B shows a cross-sectional side view of the trial sizer ofFIG. 1A taken along a plane bisecting the elongated shaft extending from the trial sizer head to the tip;FIG. 1C shows an isometric view of the trial sizer ofFIGS. 1A, 1B ;FIG. 1D shows a side view of the trial sizer ofFIGS. 1A-1C inserted into an incision in skin to an insertion point located 25 mm below the skin surface;FIG. 2A shows a cross-sectional side view of a configuration of the delivery cannula of the present kits taken along a plane bisecting the elongated body extending from the proximal end to the distal end of the delivery cannula;FIG. 2B shows a side view of the delivery cannula ofFIG. 2A ;FIG. 2C shows an isometric view of the delivery cannula ofFIGS. 2A-2B ;FIG. 3A shows a side view of a configuration of the delivery tool of the present kits;FIG. 3B shows a cross-sectional side view of the delivery tool ofFIG. 3A taken along a plane bisecting the elongated shaft extending from the delivery tool head to the distal end of the delivery tool;FIG. 3C shows an isometric view of the delivery tool ofFIGS. 3A-3B ; -
FIG. 4 shows a top view of a configuration of the present kits containing various sizes of trial sizers, delivery cannulas, and delivery tools, where the trial sizers and delivery tools are separately packaged within the sterile kit;FIG. 5A shows a cross-sectional view of a configuration of the present trial sizers inserted into a configuration of the present delivery cannula, with the tip of the trial sizer extending past the distal end of the delivery cannula at least 10 mm, with the distal end of the delivery cannula located at least 10 mm beneath the skin surface;FIG. 5B shows an isometric view of the apparatus ofFIG. 5A , with a portion of the tip of the trial sizer extending past the distal end of the delivery cannula;FIG. 6 shows a flow chart for depicting a process for sizing and delivering a soft-tissue allograft using a configuration of a trial sizer of any of the presently disclosed kits or presently disclosed apparatuses;FIG. 7A shows a cross-sectional view of the delivery cannula, inserted to a point at least 10 mm beneath the skin surface, with a dermal allograft at the distal end of the elongated shaft of the delivery tool that is inserted in the channel of the delivery cannula;FIG. 7B shows an isometric view ofFIG. 7A ;FIG. 7C shows a cross-sectional view of the apparatus ofFIG. 7A , with the delivery tool pushing the dermal allograft beyond the distal end of the delivery cannula inserted beneath the skin surface;FIG. 7D shows a side view of the apparatus ofFIG. 7C , depicting the delivery tool pushing the dermal allograft to a depth of 25 mm beneath the skin surface; andFIG. 7E shows an isometric view of the apparatus ofFIGS. 7C-7D . - In a particular configuration, such as the one shown in
FIGS. 1A-1D ,trial sizer 100 comprises: anelongated shaft 104 having aproximal end 108 and adistal end 112; and aradiopaque tip 116 coupled todistal end 112 ofelongated shaft 104, wheretip 116 has atransverse dimension 120 equal to or greater than a correspondingtransverse dimension 124 ofelongated shaft 104, and having dimensions that mimic the dimensions of a corresponding soft-tissue allograft (e.g., dermal allograft 700). For example,transverse dimension 120 may be equal to a transverse dimension of a soft-tissue allograft (e.g., dermal allograft 700) so that an operator may determine the dimensions of the allograft needed for a procedure before implanting the allograft, as described in greater detail below. - Referring to
FIG. 1B , a cross-sectional view oftrial sizer 100 is shown. In some configurations elongatedshaft 104 defines achannel 128 extending fromproximal end 108 todistal end 112. In some configurations,elongated shaft 104 is configured to indicate insertion depth oftrial sizer 100 to correspond with the insertion depth of a soft-tissue allograft. For example, as shown inFIG. 1A ,distal end 112 ofelongated shaft 104 comprises a plurality ofindicia 112 a to indicate insertion depth oftrial sizer 100 into a space (e.g., cavity such as sinus tarsi). For example, as best illustrated inFIGS. 1A and 1C , the indicia can be in the form of a depth scale. For example in some configurations, the depth scale may represent a range of dimensions (e.g., 5 mm to 40 mm) such that whentrial sizer 100 is inserted into skin, as illustrated inFIG. 1D , depth scale will indicate the depth of insertion (e.g., 25 mm inFIG. 1D ). In other configurations, depth scale may have a range with a low value is less than 5 mm and a high value that is greater than 40 mm. In some configurations the plurality ofindicia 112 a can have a depth scale that is greater than 40 mm. For example, as best illustrated inFIGS. 1E , the plurality ofindicia 112 a may range from 10 mm to 60 mm. In other configurations, the depth scale can be any range between 0 mm and a length ofelongated shaft 104. - In some configurations,
distal end 112 ofelongated shaft 104 defines one ormore threads 132 along a portion of alength 136 ofdistal end 112. In some configurations, such as the one shown inFIG. 1B ,trial sizer 100 may further include trial sizer handle 140 defining achannel 144 extending between, and through, aproximal end 148 to adistal end 152, the trial sizer handle 140 being coupled toproximal end 108 ofelongated shaft 104. In some configurations, trial sizer handle 140 is unitary withelongated shaft 104. In some configurations,channel 144 is in fluid communication withchannel 128 to define a passage throughtrial sizer 100. In some configurations,channel 128 has a transverse dimension that is less than a transverse dimension ofchannel 144, while in other configurations thetransverse dimension channel 128 may be greater than or equal to the transverse dimension ofchannel 144. - In some configurations,
radiopaque tip 116 can be uncoupled fromdistal end 112 ofelongated shaft 104 and the elongated shaft can be used to push an implant (e.g., dermal allograft 700) throughdelivery cannula 200 to aninsertion point 204 beneath the skin surface. In some configurations, the length ofradiopaque tip 116 is from 8 mm to 25 mm. Radiopaque tip may comprise any suitable material that can absorb X-rays and thus influence a radiological image. In this way,trail sizer 100 may be used during a fluoroscopy procedure so an operator may precisely determine the location ofradiopaque tip 116 while the tip is inserted within a patient. - Referring now to
FIGS. 2A-4 , some configurations of thepresent kits 400 comprise: at least one of the configurations of the presently disclosed trial sizers, and adelivery cannula 200, such as the one shown inFIGS. 2A-2C , comprising: anelongated body 208 having aproximal end 212 and adistal end 216, and defining alongitudinal channel 220 extending between, and through, the proximal anddistal ends handle portion 224 coupled toproximal end 212 ofelongated body 208, thehandle portion 224 defining achannel 228 that is aligned with and in fluid communication withlongitudinal channel 220 ofelongated body 208. In some configurations of the present kits,elongated body 208 ofdelivery cannula 200 comprises transparent material to allow depth readings of the scale (e.g., 112 a) located onelongated shaft 104 oftrial sizer 100 orelongated shaft 304 ofdelivery tool 300. - In some configurations of the
present kits 400,kit 400 further comprisesdelivery tool 300, such as the one shown inFIGS. 3A-3C . In the depicted configuration,delivery tool 300 comprises anelongated shaft 304 having aproximal end 308 and adistal end 312 that is configured to indicate insertion depth. In some configurations of the present kits,distal end 312 ofelongated shaft 304 comprises a plurality ofindicia 312 a to indicate insertion depth. In some configurations of the present kits,elongated shaft 304 ofdelivery tool 300 has adiameter 316 from 5 mm to 15 mm. In some configurations of the present kits,delivery tool 300 further comprisesdelivery tool head 320 coupled toproximal end 308 ofelongated shaft 304. In some configurations of the present kits,delivery tool head 320 is unitary withelongated shaft 304. - In some configurations of the present kits,
elongated shaft 104 oftrial sizer 100 is configured to have anouter diameter 160 from 5 mm to 15 mm. In some configurations of the present kits,delivery cannula 200 is configured to have aninner diameter 232 from 5 mm to 15 mm. Any combination oftrial sizer 100 anddelivery cannula 200 may be chosen to permittrial sizer 100 to fit withininner diameter 232 ofdelivery cannula 200 when sizing a soft-tissue allograft (e.g., dermal allograft 700) for delivery toinsertion point 204. - As best illustrated by
FIGS. 5A-5B , in some configurations of the present kits,distal end 152 of trial sizer handle 140 has afirst portion 164 with a firsttransverse dimension 168, and asecond portion 172 with a secondtransverse dimension 176 larger than firsttransverse dimension 168, the firsttransverse dimension 168 being larger than a corresponding transverse dimension 220 a oflongitudinal channel 220 ofdelivery cannula 200 to prevent thefirst portion 164 from enteringlongitudinal channel 220 ofdelivery cannula 200. - In some configurations of the present kits,
kit 400 further comprises at least one steriledermal allograft 700 having adiameter 704 about equal to anaverage width 708 of acanal 712 between a subject'smisaligned bones 716, wheredermal allograft 700 is compressible and flexible. In some configurations of the present kits,dermal allograft 700 has a density sufficient to resist full compression ofcanal 712. - In some configurations of the present kits,
kit 400 further comprises apackage 404 within which other components ofkit 400 are sealed. - Referring to
FIG. 6 , a flow chart showing amethod 600 for sizing and delivering a soft-tissue allograft using any of the configurations of the apparatuses and kits of the present disclosure is shown. The operation ofmethod 600 will be described with reference totrial sizer 100,delivery cannula 200, anddelivery tool 300, but may be performed with any of the configurations of the present trial sizers and kits of the present disclosure. - At
block 604, and as illustrated byFIGS. 5A-5B ,method 600 starts by disposingtrial sizer 100 through an incision in the skin of a patient such thatdistal end 112 oftrial sizer 100 is disposed between the incision and a given space between bones of the patient. The insertedtrial sizer 100 may be operable with any of the presently disclosed kits or of the presently disclosed apparatuses. In some configurations, delivery cannula is disposed through the incision andtrial sizer 100 is then inserted into the space. In some configurations, such as the one illustrated inFIGS. 5A-5B ,delivery cannula 200 is inserted as deep intocanal 712 as possible with the aid oftrial sizer 100. Atblock 608,method 600 continues by determining whethertrial sizer 100 fits into the space in an acceptable way, and iftrial sizer 100 fits into the space in an acceptable way, continuing to block 612 by inserting a correspondinglysized delivery cannula 200 into the space (e.g., 712). Iftrial sizer 100 does not fit into the space in an acceptable way,method 600 continues to block 608 a by sequentially repeating steps atblocks - Some methods comprise delivering an implant (e.g., dermal allograft implant 700) through
cannula 200 into the space. To deliver the implant, some methods include removingtrial sizer 100 fromdelivery cannula 200 and placing the implant (e.g., 700) into the cannula (e.g., inserting allograft implant into channel 228). The implant may then be pushed throughdelivery cannula 200 by reinsertingtrial sizer 100 or using a different tool (e.g., delivery tool 300). Some methods comprise disposing the implant into the space and removingtrial sizer 100,delivery cannula 200, and/ordelivery tool 300. - Delivery of a soft-tissue allograft (e.g., dermal allograft 700) may be performed using a trial sizer of any of the presently disclosed kits or of the presently disclosed apparatuses into the space including, for example, by uncoupling the radiopaque tip of the trial sizer and using the distal end of the elongated shaft of the trial sizer to push
dermal allograft 700 through the delivery cannula to the insertion point. In some configurations, as illustrated byFIGS. 7A-7E , delivery ofdermal allograft 700 into the space may be performed usingtrial sizer 100 of any of the presently disclosed kits or of the presently disclosed apparatuses. In other configurations, a delivery tool (e.g., 300) of any of the presently disclosed kits or of the presently disclosed apparatuses may be used to deliver an implant (e.g., 700) into the space including, for example, by usingdistal end 312 ofelongated shaft 304 ofdelivery tool 300 to pushdermal allograft 700 throughdelivery cannula 200 to the insertion point at a desired depth indicated ondistal end 312 ofdelivery tool 300 visible throughdelivery cannula 200. - Referring to
FIGS. 7F-70 , top and isometric views of a subtalar operation for inserting adermal allograft 700 into a space 720 (e.g., sinus tarsi) within a patient's foot are shown.FIGS. 7F and 7G depict thetrial sizer 100 inserted intospace 720. A correctlydimension trial sizer 100 may be determining using the method disclosed inFIG. 6 .FIGS. 7H and 71 show top and isometric views oftrial sizer 100 anddelivery cannula 200 inserted intospace 720. In the depicted embodiment,delivery cannula 200 is inserted intospace 720 beforetrial sizer 100; however, in other configurations,trial sizer 100 is inserted into the space before the delivery cannula. - Referring now to
FIGS. 7L and 7M , top and isometric views of patient's foot are shown aftertrial sizer 100 is removed fromspace 720. As shown, adermal allograft 700, or any other insert, may be placed withindelivery cannula 200. The insert may then be delivered tospace 720 vialongitudinal channel 220 ofdelivery cannula 200. As shown inFIGS. 7N and 70 trial sizer 100 may be reinserted intodelivery cannula 200 to deliver the insert intospace 720. In other configurations, another tool may be used to deliverinsert 700 throughdelivery cannula 200. For example,delivery tool 300 can be used to push the insert throughlongitudinal channel 220 ofdelivery cannula 200.Dermal allograft 700 is then disposed within space 720 (e.g., sinus tarsi) to help stabilize the skeletal or musculoskeletal system. For example,dermal allograft 700 is placed within the sinus tarsi to supplement the talocalcaneal ligament. - Some implementations of the present methods for sizing and delivering an allograft further comprise removing the delivery cannula after delivering the implant. In some configurations of the present methods for sizing and delivering an allograft, the method further comprises suturing the incision closed.
- In some implementations of the present methods for sizing and delivering a soft-tissue allograft,
delivery cannula 200 comprises anelongated body 208 having aproximal end 212 and adistal end 216, and defining alongitudinal channel 220 extending between, and through,proximal end 212 anddistal end 216, and handleportion 224 coupled toproximal end 212 ofelongated body 208, thehandle portion 224 definingchannel 228 that is aligned with and in fluid communication withlongitudinal channel 220 ofelongated body 208. - In some implementations of the present methods for sizing and delivering a soft-tissue allograft, the method further comprises inserting
delivery tool 300 comprising anelongated shaft 304 having aproximal end 308 and adistal end 312, wheredistal end 312 ofelongated shaft 304 is configured to indicate insertion depth. -
FIG. 8A shows an isometric view of another configuration of the present trial sizers. In some configurations,trial sizer 800 includes acylindrical head 804 with afirst side 808, asecond side 812, and aperipheral surface 816 extending between the first andsecond sides head 804, or any other shape particularly suited for the type of joint arthroplasty procedure. Thehandle 820 has aproximal end 824 and adistal end 828 coupled to theperipheral surface 816. Thehead 804 can have dimensions that mimic the dimensions of a corresponding soft-tissue allograft. In this way, at least some configurations of the present apparatuses can aid in determining the appropriate size and location of the soft-tissue allograft appropriate for transplantation at the site of delivery in a way that has previously not been possible with prior art trial sizers. -
FIGS. 8B-8D show an isometric view, side view, and cross-sectional view ofcylindrical head 804 of a present trial sizer. In some configurations,cylindrical head 804 may define one or more apertures (e.g., 832) going throughperipheral surface 816. Aperture(s) 832 may be used to couple handle 820 to cylindrical head.Cylindrical head 804 can be sized and shaped to correspond to a soft-tissue allograft. For example,cylindrical head 804 has alength 834 that is be greater than or equal to any one of, or between any two of: 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, or 0.75 inches (in.) (e.g., between 0.4 and 0.6 in, such as approximately 0.591 in.). - In some configurations,
head 804 is radiopaque. In some configurations, thehead 804 is unitary with thehandle 820. In some configurations, a transverse dimension of thehead 804 is from 8 mm to 20 mm. - Referring now to
FIGS. 9A-9F ,FIG. 9A shows a side view of a configuration of the present suture delivery guides.FIG. 9B shows a top view of the suture delivery guide ofFIG. 9A .FIG. 9C shows a cross-sectional view of the suture passages disposed within the suture delivery guide ofFIG. 9A and taken along a plane bisecting the suture delivery guide.FIG. 9D shows a cross-sectional side view of the suture delivery guide ofFIG. 9A taken along a plane bisecting the longitudinal dimension of the suture delivery guide.FIG. 9E shows a cross-sectional top view of the suture delivery guide ofFIG. 9D .FIG. 9F shows a cross-sectional view of the suture passages on a side of the implant chamber and taken along a plane bisecting the suture delivery guide. In some configurations,suture delivery guide 900 includes abody 904 having afirst side 908 and asecond side 912 and defining animplant chamber 916 extending through thefirst side 908 toward thesecond side 912, thebody 904 defining a plurality offirst suture passages 920 on afirst side 924 of theimplant chamber 916 and a plurality ofsecond suture passages 928 on asecond side 932 of theimplant chamber 916, each of thesecond suture passages 928 being aligned with a corresponding one of thefirst suture passages 920, thebody 904 further defining afirst slot 936 extending through thefirst side 908 of thebody 904 and in fluid communication with all of thefirst suture passages 920, and asecond slot 940 extending through thefirst side 908 of thebody 904 and in fluid communication with all of thesecond suture passages 928. - In some configurations, the
body 904 has amedial portion 944 that defines theimplant chamber 916 and twolateral portions medial portion 944. A first one of thelateral portions 948 a defines thefirst suture passages 920, and a second one of thelateral portions 948 b defines thesecond suture passages 928. - In some configurations, each of two of the
first suture passages 920 a and a corresponding each of two of thesecond suture passages 928 a is intersected by a reference plane (B-B) that extends parallel to the first andsecond slots second sides body 904. - In some configurations, a set of two of the
first suture passages 920 b and a corresponding set of two of thesecond suture passages 928 b is arranged relative to a reference plane (B-B) that extends parallel to the first andsecond slots second sides body 904, such that the set of two of thefirst suture passages 920 b are disposed on opposite sides of the plane, and the corresponding set of two of thesecond suture passages 928 b are disposed on opposite sides of the plane (B-B). - Referring now to
FIGS. 9G-91 ,FIG. 9G shows a cross-sectional side view of a second configuration of the suture delivery guide.FIG. 9H shows a top view of the suture delivery guide of 9G.FIG. 9I shows a cross-sectional view of the suture passages on a side of the implant chamber and taken along a plane bisecting the suture delivery guide. In this configuration, components are similar (e.g., in structure and/or function) to components discussed with reference toFIGS. 9A-9F . In some configurations,implant chamber 916 comprises a maximumtransverse dimension 952 between 4 mm to 20 mm. In some configurations,suture delivery guide 900 may contain a laser etching (e.g., 956) that contains information about the suture delivery guide. For example, a dimension, orientation, logo, or other information may be included in the laser etching. - In some configurations of the present kits, a kit comprises: at least one of a configuration of any of the presently disclosed trial sizers (e.g., 800); and at least one of a configuration of any of the presently disclosed suture delivery guides (e.g., 900).
- In some configurations of the present kits, the kit further comprises: at least one sterile
dermal allograft 516 having a diameter about equal to an average width of a canal between a subject's bones, where thedermal allograft 516 is compressible and flexible. - In some configurations of the present kits, the dermal allograft has a density sufficient to resist full compression.
- In some configurations of the present kits, the kit further comprises a package within which the other components of the kit are sealed.
- Implementation of the present methods will be discussed with reference to
trial sizer 800,suture delivery guide 900 and the hand bones shown inFIGS. 11A-11C .FIG. 11A shows a top view of the thumbmetacarpal bone 500, carpometacarpal joint 504,trapezium 508, andcarpal bones 512 of the hand.FIG. 11B shows a sagittal view of the hand bones ofFIG. 11A .FIG. 11C shows an isometric view of the hand bones ofFIG. 11A . - In some implementations of the present methods, a method includes: (a) inserting a trial sizer (e.g., 800) of any of the kits presently disclosed or any configuration of the trial sizers presently disclosed into a given space between bones of the patient, such as, for example, the space occupied by the
trapezium bone 508 in the carpometacarpal joint 504; (b) determining whether the trial sizer (e.g., 800) fits into the space in an acceptable way, and (i) if the trial sizer (e.g., 800) fits into the space in an acceptable way, delivering a soft-tissue allograft 516 to the space; or (ii) if the trial sizer (e.g., 800) does not fit into the space in an acceptable way, sequentially repeating steps (b) and (c) with a trial sizer of a different size until a trial sizer fits into the space in an acceptable way. - In some implementations, a bone (e.g., the trapezium bone 504) is excised prior to inserting
trial sizer 800. As best illustrated inFIGS. 12A-12C , in some implementations theperipheral surface 816 of thehead 804 of thetrial sizer 800 faces bone in a preferred orientation. As best illustrated inFIGS. 13A-13C , in some implementations thefirst end 808 and thesecond end 812 of thehead 804 of thetrial sizer 800 faces bone in a preferred orientation. - Once the preferred orientation is determined, delivery of a soft-tissue allograft, such as
dermal allograft 516, to the space between the bones may include using a suture delivery guide such as the one shown inFIGS. 9A-9F . The suture delivery guide may include any configuration of the suture delivery guides presently disclosed. - In some implementations, delivering an
implant 516 to the space includes: inserting a suture anchor in the distal aspect of the 2ndmetacarpal bone 520; and fastening a soft-tissue allograft 516 to the suture anchor. - Referring now to
FIGS. 9A-9F, and 10A-10B , delivery of a soft-tissue allograft 516 to the space in the same orientation as thetrial sizer 800 ofFIGS. 13A-13C usingsuture delivery guide 900 will be described. As best illustrated byFIG. 10B , in some implementations, delivering a soft-tissue allograft 516 to the space includes passing asuture 528 through one of a first set ofsuture passages 920 a, throughimplant 516, and then through a corresponding one of a second set ofsuture passages 928 a, and then looping thesuture 528 through a flexor carpi radialistendon 524 of the patient. Thesuture 528 is then looped back through the other one of the second set ofsuture passages 928 a, back through soft-tissue allograft 516, and then through the other one of the first set ofsuture passages 920 a. Thesuture 528 is then slipped out of first andsecond slots dermal allograft 516 to be delivered over thesuture 528 and into the space between bones of the patient (e.g., as shown inFIGS. 15A-15C , the space previously occupied by the trapezium bone between the 1stmetacarpal bone 500 and the scaphoid bone 532); and (d) tying thesuture 528 using an acceptable surgical knot. - Alternatively, in some implementations, delivering an
implant 516 to the space can be in the same orientation as thetrial sizer 800 ofFIGS. 12A-12C . As best illustrated byFIG. 10A , in some implementations, delivering a soft-tissue allograft 516 to the space includes passing asuture 528 through one of a first set ofsuture passages 920 b, throughimplant 516, and then through a corresponding one of a second set ofsuture passages 928 b, and then looping thesuture 528 through a flexor carpi radialistendon 524 of the patient. Thesuture 528 is then looped back through the other one of the second set ofsuture passages 928 b, back throughimplant 516, and then through the other one of the first set ofsuture passages 920 b. Thesuture 528 is then slipped out of first andsecond slots dermal allograft 516 to be delivered over thesuture 528 and into the space between bones of the patient (e.g., as shown inFIGS. 14A-14C , the space previously occupied by the trapezium bone between the 1stmetacarpal bone 500 and the scaphoid bone 532); and (d) tying thesuture 528 using an acceptable surgical knot. - In some implementations of the present methods, a method comprises: providing at least one sterile pre-formed allograft rod plug having a diameter about equal to an average width of a space between a person's bones and a density sufficient to resist full compression of the space, the pre-formed allograft rod plug being resiliently compressible and flexible while remaining substantially as the formed plug; and delivering the at least one sterile pre-formed allograft rod plug into the space between a set of bones of the patient, where the set of bones is selected from the group of sets of bones consisting of: (a) a 1st metacarpal bone and a scaphoid bone; (b) a 4th metatarsal bone, 5th metatarsal bone, and cuboid bone; (c) a 5th metatarsal bone; (d) a tibia bone and a talus bone; (e) a radius bone and a humerus bone; (f) a femur bone and a pelvis bone; (g) any of the proximal phalanges of a hand and any of the corresponding intermediate phalanges of a hand.
- In some implementations, a portion or all of a patient's trapezium bone is removed to manually create a space prior to delivering the at least one sterile dermal allograft.
- In some implementations, a trial sizer (e.g., 800) is inserted into the space created between the 1st
metacarpal 500 and thescaphoid bone 532 of the patient's hand prior to delivering the at least one steriledermal allograft 516. For example, as shown inFIGS. 12A-12C ,trial sizer 800 may be oriented where theperipheral surface 816 of thehead 804 of thetrial sizer 800 faces bone, or alternatively oriented where the first andsecond sides head 804 oftrial sizer 800 face bone. Whichever orientation is determined by the health care provider to be an acceptable orientation, thedermal allograft 516 may then be delivered and oriented similarly. For example, as shown inFIGS. 14A-14C ,dermal allograft 516 is oriented in a first orientation similar to the orientation of the trial sizer inFIGS. 12A-12C . Alternatively, as shown inFIGS. 15A-15C ,dermal allograft 516 is oriented in a second orientation similar to the orientation of the trial sizer inFIGS. 13A-13C . - In some implementations, the space to be filled with
dermal allograft 516 is between the 4th and 5th metatarsal bones of the foot and the cuboid bone of the foot. - In some implementations, the space to be filled with
dermal allograft 516 is between a tibia bone and a talus bone of the patient. - In some implementations, the space to be filled with
dermal allograft 516 is between a radius bone and a capitellum portion of a humerus bone of the patient. - In some implementations, the space to be filled with
dermal allograft 516 is between a femur bone and a pelvis bone of the patient. - In some implementations, the space to be filled with
dermal allograft 516 is between any of the proximal phalanges of a hand and any of the corresponding intermediate phalanges of a hand. Other clinical indications may also benefit from implementation of the methods presently disclosed. - The above specification and examples provide a complete description of the structure and use of exemplary configurations. Although certain configurations have been described above with a certain degree of particularity, or with reference to one or more individual configurations, those skilled in the art could make numerous alterations to the disclosed configurations without departing from the scope of this invention. As such, the various illustrative configurations of the present devices, apparatuses, kits, and methods are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and configurations other than the one shown may include some or all of the features of the depicted configuration. For example, components may be combined as a unitary structure, and/or connections may be substituted. Further, where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one configuration or may relate to several configurations.
- The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively.
Claims (22)
1-20. (canceled)
21. A method for delivering an implant, the method comprising:
(a) inserting a trial sizer into a given space between bones of a patient;
(b) determining whether the trial sizer fits into the space in an acceptable way, and:
(i) if the trial sizer fits into the space in an acceptable way, delivering the implant to the space; or
(ii) if the trial sizer does not fit into the space in an acceptable way, sequentially repeating steps (a) and (b) with a trial sizer of a different size until a trial sizer fits into the space in an acceptable way.
22. The method of claim 21 , further comprising excising a bone in a patient prior to inserting the trial sizer.
23. The method of claim 22 , wherein the bone is a trapezium bone.
24. The method of claim 21 , wherein the space between bones is the space occupied by the trapezium bone in the carpometacarpal joint.
25. The method of claim 21 , wherein a peripheral surface of a head of the trial sizer faces bone.
26. The method of claim 25 , wherein a first side and a second side of the head of the trial sizer faces bone.
27. The method of claim 21 , wherein delivering the implant to the space comprises using a suture delivery guide.
28. The method of claim 27 , wherein the suture delivery guide comprises:
a body having a first side and a second side and defining an implant chamber extending through the first side toward the second side, the body defining a plurality of first suture passages on a first side of the implant chamber and a plurality of second suture passages on a second side of the implant chamber, each of the second suture passages being aligned with a corresponding one of the first suture passages, the body further defining a first slot extending through the first side of the body and in fluid communication with all of the first suture passages, and a second slot extending through the first side of the body and in fluid communication with all of the second suture passages.
29. The method of claim 21 , wherein delivering the implant to the space comprises:
(a) passing a suture through the implant and looping the suture through a flexor carpi radialis tendon;
(b) looping the suture back through a soft-tissue allograft;
(c) delivering the allograft over the suture and into the space between bones of the patient; and
(d) tying the suture using an acceptable surgical knot.
30. The method of claim 21 , further comprising inserting a delivery cannula into the space.
31. The method of claim 30 , further comprising:
after delivering the soft-tissue allograft, removing the delivery cannula.
32. The method of claim 31 , where the delivery cannula comprises an elongated body having a proximal end and a distal end, and defining a longitudinal channel extending between, and through, the proximal end and the distal end, and a handle portion coupled to the proximal end of the elongated body, the handle portion defining a channel that is aligned with and in fluid communication with the longitudinal channel of the elongated body.
33. The method of claim 21 , wherein the trial sizer is selected from a kit having more than one trial sizers.
34. The method of claim 21 , further comprising inserting a suture anchor into a first bone.
35. The method of claim 34 , wherein the first bone is a second metacarpal.
36. The method of claim 34 , wherein the suture anchor is inserted into a distal aspect of the first bone.
37. The method of claim 34 , further comprising fastening a soft-tissue allograft to the suture anchor.
38. A method for delivering an allograft, the method comprising:
providing at least one sterile pre-formed soft-tissue allograft rod plug, the pre-formed soft-tissue allograft rod plug being resiliently compressible;
delivering the at least one sterile pre-formed soft-tissue allograft rod plug into the space between a set of bones of the patient.
39. The method of claim 38 , wherein the pre-formed allograft rod plug has a diameter about equal to an average width of a space between a person's bones and a density sufficient to resist full compression of the space.
40. The method of claim 38 , wherein the pre-formed allograft rod plug is resiliently compressible and flexible while remaining substantially as the formed plug.
41. The method of claim 38 , wherein the space between bones is the space occupied by the trapezium bone in the carpometacarpal joint.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US18/078,579 US20230181339A1 (en) | 2018-06-21 | 2022-12-09 | Systems and methods for sizing and introduction of soft-tissue allografts |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201862687901P | 2018-06-21 | 2018-06-21 | |
US16/449,022 US11547579B2 (en) | 2018-06-21 | 2019-06-21 | Systems and methods for sizing and introduction of soft-tissue allografts |
US18/078,579 US20230181339A1 (en) | 2018-06-21 | 2022-12-09 | Systems and methods for sizing and introduction of soft-tissue allografts |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/449,022 Continuation US11547579B2 (en) | 2018-06-21 | 2019-06-21 | Systems and methods for sizing and introduction of soft-tissue allografts |
Publications (1)
Publication Number | Publication Date |
---|---|
US20230181339A1 true US20230181339A1 (en) | 2023-06-15 |
Family
ID=68981199
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/449,022 Active 2040-02-07 US11547579B2 (en) | 2018-06-21 | 2019-06-21 | Systems and methods for sizing and introduction of soft-tissue allografts |
US18/078,579 Pending US20230181339A1 (en) | 2018-06-21 | 2022-12-09 | Systems and methods for sizing and introduction of soft-tissue allografts |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/449,022 Active 2040-02-07 US11547579B2 (en) | 2018-06-21 | 2019-06-21 | Systems and methods for sizing and introduction of soft-tissue allografts |
Country Status (1)
Country | Link |
---|---|
US (2) | US11547579B2 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9943414B2 (en) * | 2015-12-30 | 2018-04-17 | Wasas, Llc. | System and method for non-binding allograft subtalar joint implant |
Family Cites Families (34)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3745590A (en) | 1971-06-25 | 1973-07-17 | Cutter Lab | Articulating prosthesis with ligamentous attachment |
US4450591A (en) | 1981-12-10 | 1984-05-29 | Rappaport Mark J | Internal anti-proratory plug assembly and process of installing the same |
FR2704142B1 (en) | 1993-04-23 | 1995-07-07 | Jbs Sa | Ball joint prosthesis for the basal joint of the thumb. |
US5645605A (en) | 1995-09-18 | 1997-07-08 | Ascension Orthopedics, Inc. | Implant device to replace the carpometacarpal joint of the human thumb |
US6017366A (en) | 1997-04-18 | 2000-01-25 | W. L. Gore & Associates, Inc. | Resorbable interposition arthroplasty implant |
FR2763835A1 (en) | 1997-05-30 | 1998-12-04 | Michel Lahille | Carpometacarpal implant |
US6168631B1 (en) | 1997-08-29 | 2001-01-02 | Kinetikos Medical, Inc. | Subtalar implant system and method for insertion and removal |
US6241729B1 (en) * | 1998-04-09 | 2001-06-05 | Sdgi Holdings, Inc. | Method and instrumentation for posterior interbody fusion |
US20070233272A1 (en) | 1999-02-23 | 2007-10-04 | Boyce Todd M | Shaped load-bearing osteoimplant and methods of making same |
US20040049270A1 (en) | 2002-09-10 | 2004-03-11 | Gewirtz Robert J. | Bone graft device |
WO2005070328A1 (en) | 2004-01-09 | 2005-08-04 | Regeneration Technologies, Inc. | Muscle-based grafts/implants |
WO2005070439A1 (en) | 2004-01-09 | 2005-08-04 | Regeneration Technologies Inc. | Implant comprising a human muscle tissue matrix |
US8092547B2 (en) | 2004-02-10 | 2012-01-10 | Tornier, Inc. | Subtalar implant assembly |
EP1835867A2 (en) | 2004-11-30 | 2007-09-26 | Osteobiologics, Inc. | Implants and delivery system for treating defects in articulating surfaces |
US20060241777A1 (en) | 2004-11-30 | 2006-10-26 | Partin Jason I | Resorbable medical implants and methods |
CA2606445C (en) | 2005-04-29 | 2014-09-16 | Cook Biotech Incorporated | Volumetric grafts for treatment of fistulae and related methods and systems |
EP1903947B1 (en) | 2005-06-21 | 2015-12-30 | Cook Medical Technologies LLC | Implantable graft to close a fistula |
US20070021839A1 (en) | 2005-07-21 | 2007-01-25 | William Lowe | Trapezium prosthesis and method |
CA2637450A1 (en) | 2006-01-31 | 2007-08-09 | Cook Biotech Incorporated | Fistula grafts and related methods and systems for treating fistulae |
US20080269908A1 (en) | 2007-04-27 | 2008-10-30 | Piper Medical, Inc. | Carpometacarpal (cmc) joint arthoplasty implants and related jigs, medical kits and methods |
US20090061389A1 (en) | 2007-08-30 | 2009-03-05 | Matthew Lomicka | Dental implant prosthetic device with improved osseointegration and shape for resisting rotation |
US9119613B2 (en) | 2008-01-07 | 2015-09-01 | Extremity Medical Llc | System and method for trapezium bone replacement |
WO2010006270A1 (en) | 2008-07-11 | 2010-01-14 | Integra Lifesciences Corporation | Resorbable medical implants and related methods |
DK2393453T3 (en) | 2009-02-06 | 2012-09-10 | Ortho Space Ltd | Expandable joint implant |
US20100256758A1 (en) | 2009-04-02 | 2010-10-07 | Synvasive Technology, Inc. | Monolithic orthopedic implant with an articular finished surface |
US20140074247A1 (en) | 2009-05-08 | 2014-03-13 | Kevin L. Ohashi | Joint reconstruction system and method |
WO2010151589A1 (en) | 2009-06-23 | 2010-12-29 | Replication Medical, Inc. | Trapezium prosthesis |
US20110054627A1 (en) | 2009-09-01 | 2011-03-03 | Bear Brian J | Biologic Soft Tissue Arthroplasty Spacer and Joint Resurfacing of Wrist and Hand |
US8834568B2 (en) | 2010-02-04 | 2014-09-16 | Paul S. Shapiro | Surgical technique using a contoured allograft cartilage as a spacer of the carpo-metacarpal joint of the thumb or tarso-metatarsal joint of the toe |
WO2013075091A1 (en) | 2011-11-17 | 2013-05-23 | Allosource | Multi-piece machine graft systems and methods |
US8641770B2 (en) | 2012-01-26 | 2014-02-04 | Aptis Medical, Llc | Prosthesis for the basal joint of the thumb |
US20130282121A1 (en) | 2012-03-22 | 2013-10-24 | Ann Prewett | Spinal facet augmentation implant and method |
US9943414B2 (en) | 2015-12-30 | 2018-04-17 | Wasas, Llc. | System and method for non-binding allograft subtalar joint implant |
US10945831B2 (en) | 2016-06-03 | 2021-03-16 | Musculoskeletal Transplant Foundation | Asymmetric tissue graft |
-
2019
- 2019-06-21 US US16/449,022 patent/US11547579B2/en active Active
-
2022
- 2022-12-09 US US18/078,579 patent/US20230181339A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
US20190388246A1 (en) | 2019-12-26 |
US11547579B2 (en) | 2023-01-10 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US10123879B2 (en) | System and method for non-binding allograft subtalar joint implant | |
US7959681B2 (en) | Cannulated hemi-implant and methods of use thereof | |
US8075634B2 (en) | Orthopedic device | |
EP1528895A1 (en) | Method and apparatus for repairing the mid-food region via an intermedullary nail | |
US11883038B2 (en) | Implants, devices, systems, kits and methods of implanting | |
ST ELMO III | An artificial ankle joint | |
US11273045B2 (en) | Motion toe systems and methods | |
Younger et al. | Polyvinyl alcohol hydrogel hemiarthroplasty of the great toe: technique and indications | |
US20230181339A1 (en) | Systems and methods for sizing and introduction of soft-tissue allografts | |
Taranow et al. | Contemporary approaches to stage II and III hallux rigidus: the role of metallic hemiarthroplasty of the proximal phalanx | |
Coriaty et al. | Titanium scaffolding: an innovative modality for salvage of failed first ray procedures | |
Irgit et al. | Flexible progressive collapsing foot deformity: is there any role for arthroereisis in the adult patient? | |
Ellis et al. | The INBONE total ankle replacement | |
Burton | Basal joint implant arthroplasty in osteoarthritis: indications, techniques, pitfalls, and problems | |
JP6704917B2 (en) | Talar implants for modifying joint kinematics | |
US10595915B2 (en) | Bone implant devices, instruments and methods of use | |
Fuhrmann | MTP prosthesis (Reflexion™) for hallux rigidus | |
Hintermann | Surgical techniques | |
Paley | Paley Cross-Union Protocol for Treatment of Congenital Pseudarthrosis of the Tibia | |
Alvine et al. | Total Ankle Arthroplasty Using the Agility Stemmed Talar Revisional Component: Three to Eight Year Follow-Up. | |
US20230149178A1 (en) | Cannulated bone implant and methods of use | |
Sodha et al. | Evolution of total ankle arthroplasty | |
So et al. | A 3D-printed solution for evans calcaneal osteotomy nonunion | |
Taranow et al. | Metallic proximal phalangeal hemiarthroplasty for hallux rigidu | |
Nowak et al. | Custom constrained 3D total talus/navicular replacement |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |
|
AS | Assignment |
Owner name: ARTHROSURFACE, INC., MASSACHUSETTS Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:JAWRANI, NIKHIL T.;EK, STEVEN W.;SIGNING DATES FROM 20180717 TO 20180720;REEL/FRAME:063146/0829 |