Patent Application
20240261085
All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Connective tissues, including tendons and ligaments, provide joint stability, guide joint motion, and play an important role in proprioception. Injury to ligaments and tendons represents a major portion of all sports-related injuries on an annual basis. In particular, rotator cuff injuries are particularly prevalent and difficult to repair.
The rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of your upper arm bone firmly within the shallow socket of the shoulder. A rotator cuff injury can cause a dull ache in the shoulder, which often worsens when you try to sleep on the involved side. Rotator cuff injuries occur most often in people who repeatedly perform overhead motions in their jobs or sports. Examples include painters, carpenters, and people who play baseball or tennis, although rotator cuff tears may occur as a result of a single injury. The risk of rotator cuff injury increases with age.
Extensive rotator cuff tears typically require surgical repair, however current techniques are not optimal, and may be difficult or impossible to achieve, or may fail days or months after surgery. In particular, these regions are difficult to access, and even when accessed may be difficult to operate within. Although grafts and repair techniques are known, it has proven particularly difficult to implant or insert these typically flat (e.g., postage-stamp or larger) sized implants, which may be somewhat delicate, as they may be include biological (e.g., bone) material. Current standard of care for reattaching connective tissues (ligament, tendon) to bone typically uses suture and suture anchors to reattach the connective tissue to the bone. Re-tearing of the connective tissue is common and occurs in over half of the cases. Further, full mobility and pain relief are not generally possible.
Thus, there is a need for tools and methods for implanting connective tissue-to-bone interface grafts. Further, there is a need for methods and tools for delivering and securing such graft to the bone.
Described herein are tools and methods for delivering and securing graft implants in a patient's body, especially connective tissue-to-bone interface grafts for repair of the enthesis, including ligament to bone and tendon to bone interface scaffolds for repair of torn tendons, ligaments, and/or calcified and uncalcified fibrocartilage.
Described herein are methods and apparatuses for repairing tissue, including, but not limited to repairing an enthesis. Also described herein are methods and apparatuses for delivering and securing graft implants to tissue at a target location within a patient's body. The apparatuses (e.g., devices and/or systems, including tools) and methods described herein are well suited for use in the delivery and implantation of grafts between connective tissue, such as ligament, and bone. For example, in some implementations, the apparatuses and methods described herein are used in the delivery and implantation of connective tissue-to-bone interface scaffolds (e.g., ligament-to-bone interface scaffolds, tendon-to-bone interface scaffolds, etc.).
The apparatuses and methods described herein may involve temporary fixation of a graft at the site of repair, for example, to prevent movement of the graft while the graft is being permanently secured to the site of repair between the bone and connective tissue. Temporary fixation may involve placement of a retention component, such as a removable securement (e.g., a suture, removable anchor, removable pin, removable staple, etc.) that is configured to temporarily hold the graft in place only until the connective tissue (e.g., ligament) is secured over the graft, so that the graft is sandwiched securely between the connective tissue and a region of decorticated bone. Once the graft is secured between the connective tissue and decorticated bone, the removable securement can be removed from the graft, and from the patient's body, thereby minimizing concerns of foreign body response or tissue damage (e.g., compared to a long-term implanted component). Such techniques can also reduce surgical complexity and avoid time-intensive biocompatibility characterization and mechanical validation of using long-term implanted components. In particular, these methods and apparatuses allow a graft to be secured (including permanently secured) in place between connective tissue (e.g., ligament) and decorticated bone without any other material (e.g., suture, pin, staple, etc.) disposed between the connective tissue and graft or bone and graft, which is a significant benefit in reducing the likelihood of complications and post-surgical discomfort and may reduce healing times.
The apparatuses described herein include removable securements, which in some configurations comprises removable sutures and/or pins and/or staples. The apparatuses described herein also include removable securement delivery tools for delivering one or more removable securements. A removable securement delivery tool may be configured as a puncture tool configured to form small holes within the bone, which may be referred to herein as marrow vents or microfractures, deep enough to access and allow bone marrow material to migrate into the graft positioned over the vents or microfractures. Transfer of marrow into the graft may increase endogenous growth factors and stems cells at the site of graft implantation, which may have a therapeutic benefit and promote healing. The removable securement delivery tools described herein may also be adapted to deliver one or more removable securements to temporarily hold the graft in place.
Although the methods and apparatuses (e.g., devices and systems, including tools) can be used during any of a number of graft implant procedures, they may be especially well suited for use during implantation of connective tissue-to-bone interface grafts (e.g., scaffolds). Such connective tissue-to-bone interface grafts may be used to repair of ligaments, tendons, cartilage or growth plates in the shoulder, hand, elbow, knee, foot, ankle or any other anatomical location as needed. Furthermore, the grafts may be applied to replace or repair any of a variety of joints. Any appropriate tissue may be repaired, including, but not limited to rotator cuff tissue.
The connective tissue-to-bone interface grafts may have a porous structure to provide a large surface area for exchange of nutrient and waste. In some examples, the grafts may be formed of a bone material that has been processed to form a layered structure having a first porous layer that is demineralized and a second porous layer that is mineralized. The graft may be a strip, having an elongate, flattened sheet or strip-like configuration, in which the first (e.g., upper) major side is mineralized and the second (e.g., lower) major side is demineralized. The edges between the first and second side (minor sides) may be rounded or beveled. The demineralize layer thickness may be larger than the thickness of the mineralized layer (e.g., 60% or greater, 65% or greater, 70% or greater, 75% or greater, etc. of the thickness of the graft).
The cortical layer may be removed from the implantation site for the graft prior to removably attaching the graft. In addition, microfractures may be formed in the bone, to further expose the marrow. For example, for a humeral procedure, the humerus may decorticated and alternatively or additionally microfractures formed at the site onto which the graft is to be applied. For example, the bone (e.g., humerus) may be prepared by removing a region of the cortical layer, e.g., to form a shelf or landing pad region to which the graft may be attached. Alternatively or additionally, in some examples the bone (e.g., humerus) may be prepared by forming microfractures to the region to which the graft will be attached, without removing a region. In some examples both a region of the bone may be removed, and the bone may be treated to form microfractures.
For example, a method of repairing a tissue (e.g., a method of repairing a rotator cuff) may include: removing a region of a cortical layer of a bone (e.g., a humerus) to form a decorticated surface; positioning a graft over the decorticated surface; temporarily securing a mineralized face of the graft on the decorticated surface with a removable securement, wherein the mineralized face has a thickness that is less than a demineralized face of the graft that is adjacent to the mineralized face; suturing a tendon against the demineralized face of the graft with one or more sutures that do not pass through the graft; and removing the removeable securement from the graft so that the graft is held against the decorticated surface by just the surgically repaired tendon. The surgical repair of the tendon to bone provides the retention force after the removeable securement is removed.
As mentioned, in general, the removable securement may be a retention device. Thus, the removable securement may include one or more penetrating arms, e.g., prongs, and a tether (e.g., “pull suture”) that may allow the removable securement to be removed (or partially removed) so that it is not between the graft and the tendon or the graft and the bone. For example, the removable securement may include one or more prongs for penetrating into the bone, and in particular, the decorticated bone. Thus, any of these methods may include passing one or more prongs of the removable securement through the graft and into the decorticated surface.
In general, the removable securement may be removed without disturbing the tendon or tendon fixation system (i.e. suture), which is attached over the graft, to the bone. For example, removing the removable securement may include removing the removable securement from between the graft and the tendon, leaving the tendon sutured against the graft.
In some examples, temporarily attaching the graft may also beneficially add one or more openings for the passage of marrow cells from the bone into the graft; this may be done in addition to decorticating the bone. For example, any of these methods may include temporarily securing the graft by driving one or more prongs of a removeable securement through the decorticated surface to create one or more marrow vents within the humerus into a marrow material. Removing the removeable securement may include removing the one or more prongs from the decorticated surface, thereby causing the marrow material to exit the one or more marrow vents and into the graft. In some examples removing the removeable securement comprises removing the one or more prongs from the decorticated surface by pulling a tether (e.g., pull suture) attached to the removeable securement. Pulling the tether may include pulling the pull suture in a non-perpendicular direction with respect to a long axis of the one or more prongs. In some examples, pulling the tether causes the removeable securement to pivot such that the one or more prongs exit corresponding one or more opening within the decorticated surface.
Any of these methods may include forming microfractures in the decorticated surface cither before or during removably attaching the removable securement. A separate tool may be used to form microfractures, or the same tool used to removably attach the removable securement may be used.
Any of these steps may be performed minimally invasively, including arthroscopically, e.g., through a cannula or introducer. For example, decorticating the bone surface may be done arthroscopically (e.g. using a burr or other tool). The graft, and in particular, the flexible grafts described herein (including those described in U.S. patent application Ser. No. 17/015,043, titled “CONNECTIVE TISSUE TO BONE INTERFACE SCAFFOLDS,” filed on Sep. 8, 2020, herein incorporated by reference in its entirety) may be inserted arthroscopically, and positioned over the decorticated surface. The step of temporarily securing the graft on the decorticated surface with a removable securement may be done minimally invasively as well, including using any of the tools described herein to temporarily secure the graft. The tendon may be sutured to the bone using arthroscopic techniques, including placing the anchors (e.g., suture anchors) to the bone. Finally, the removeable securement may be removed from the graft so that the graft is held against the decorticated surface by just the surgically repaired tendon by a minimally invasive (e.g., arthroscopic) technique.
The methods described herein may also include (in some examples when suturing the tendon) anchoring the one or more tendon-securing sutures to the humerus outside of the decorticated region. It may be beneficial to anchor the tendon-securing sutures via one or more anchors that are outside of the decorticated region, and also separate from the graft. The tendon may be secured in place by any appropriate means, e.g., using two or more sutures that may, e.g. cross over the tendon one or more times.
Any of the methods described herein may be methods of repairing an enthesis.
In general, these methods may be used to treat any appropriate tissue, including (but not limited to) shoulder and knee tissues. For example, suturing the tendon may include suturing the tendons of one or more of: the supraspinatus muscle, infraspinatus muscle teres minor muscle or the subscapularis muscle.
The methods described herein may be performed as part of a single, acute procedure. Thus, the removable securement may be removably attached through the graft, the connective tissue (e.g., tendon) secured to the bone and the removable securement removed, all during the same procedure. For example, the removable attachment may be removed from the bone within less than 2 hours of attaching it through the graft, e.g., less than 1.5 hours, less than 1 hour, less than 45 minutes, less than 30 min, etc.
Also described herein are removable securement delivery tools. These tools may be used to secure the graft, temporarily, to the decorticated bone using a removable securement, and/or to assist in removing the removable securement. In some examples, the removable securement may be loaded into the removable securement delivery tool, or multiple removable securements may be loaded to the tool. The tool may direct the tether coupled to the one or more securements so that they do not get entangled.
For example, a removable securement delivery tool may include: a handle; and an elongate body attached to a proximal handle, a distal end of the elongate body including a delivery portion configured to deliver a removeable securement into a bone, wherein the deliver portion includes one or more pins adapted to fit through and engage with one or more tubular posts (e.g., prongs) of the removeable securement, each of the one or more pins including a sharp distal tip configured to penetrate bone and create a microfracture hole within the bone, wherein the delivery portion is adapted to release the removeable securement such that the one or more tubular posts of the removeable securement remain within the one or more microfracture holes (until the removable securement is removed).
The delivery portion may include an engagement surface that is adapted to engage with a flange portion of the removeable securement. The one or more pins may be configured to translate relative to the engagement surface, e.g., so that they can be removed from the removable engagement, e.g., removed from out of the hollow, and in some cases cylindrical, posts or prongs of the removable securement. The one or more pins may include a sharp distal end that may penetrate the bone (e.g., the decorticated bone region).
The side of the elongate body of the tool may include one or more channels configured to accommodate the tether of the removeable securement. The channel may be recessed (as a groove) and may be open or partially open, or it may be enclosed.
In some examples the delivery portion of the removable securement delivery tool is specifically configured or adapted for use with a particular type of removable securement. For example the delivery portion may include one or more pins adapted to fit through and engage with one or more tubular posts (prongs) of the removeable securement. For example, in some cases the delivery portion includes two pins adapted to fit through and engage with two tubular posts (prongs) of a removeable securement.
Also described herein are removeable securements that are adapted for use during a repair procedure (e.g., rotator cuff repair procedure). The removeable securement may include: a flange having a substantially flat surface; one or more tethers coupled to the flange; and one or more posts extending proud from the flange, each of the one or more posts having a central opening extending therethrough, wherein the outer surface of the one or more posts is adapted to releasably engage with a decorticated bone. The tether may be a suture or other material, including polymeric, metallic, or natural (e.g., fibers) that have sufficient strength to allow the removable securement to be removed by pulling on the tether without the tether breaking. For example the tether may be made of a synthetic non-absorbable material. In some examples the tether has a diameter of between about 0.01 mm and 1 mm (e.g., between about 0.1 mm and about 0.8 mm, etc.).
The flange region may be configured to prevent the removable securement from penetrating too deeply into the graft and bone. The flange region also prevents the graft from pulling over the removable securement. In some cases the flange region has a surface area that is sufficiently large to prevent damage to the graft during insertion. For example, the flange region, which may also be referred to as a head region, may have an area that is approximately 4× the cross-sectional area of the one or more prongs in a plane parallel with the primary plane of the flange region. (e.g., parallel with the graft, when inserted). The flange may be rounded.
The flange region may be flat (e.g., substantially planar, particularly on the graft-facing surface, or it may be curved). The flange region may extend in a plane that is substantially perpendicular to the direction of the prongs, or in some cases, at an angle of between about 100 and 160 degrees, relative to the prongs; in some case this angle may making removing the removable securement easier, particularly when removing the removable securement from underneath of the tendon at an angle.
The prongs (posts) may be configured so that they may be removed by applying a reasonably low force to the tether to remove them from the tissue. In some examples the one or more prongs (posts) may have a smooth outer profile. The outer profile may be tapered. In some examples the prongs (posts) may be relatively smooth, and/or may be formed of and/or coated with a lubricious material (e.g., Teflon, silicone, etc.). In some cases the prongs may be treated with a dissolvable and/or collapsible material that may reduce the force required to remove the prongs (posts) over the short period of time they are in the body during the procedure (e.g., within 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, etc.).
In some examples the flange has a C-shape or a U-shape; in some examples the flange has an oval shape or a half-moon shape. The removable securement may include one or more openings to which the one or more tethers are coupled. In some examples, the tether is coupled to the flange region. In some examples the flange is coupled to an extension or projection of the flange region.
The flange region may be relatively thin. For example, the flange region may have a transverse thickness of less than about 2 mm, less than about 1.5 mm, less than about 1 mm, etc.
In some examples, the prongs (posts) are configured to penetrate the graft, but not penetrate more than shallowly into the bone (e.g., the decorticated bone). For example, for grafts that are between about 2 mm and about 8 mm thick, the prongs (posts) of the removeable securement may each have a length of between about 3 and about 9 mm (e.g., from about 3.5 mm to 10 mm, etc.). In some examples the removable securement dimensions may be matched to the dimensions (thickness) of the graft to be inserted. In some examples the length of the prong (post) may be between about 0.5 and about 4 mm (e.g., between about 0.5 and about 3 mm, between about 0.5 and 2 mm, etc.) longer than the thickness of the graft. In some cases the prongs (posts) may have a diameter or between about 0.8 mm and 3 mm (e.g., between about 0.8 mm and 2 mm, between about 0.8 mm and 1.5 mm, etc.) on average. In some cases the prongs/posts may be tapered along at least the bone-penetrating length of the prong, which may make them easier to remove when pulling the tether. For example, the distal end region of the prong (post) may be tapered over the last few mm.
Although many of the examples described herein are configured to remove the entire removable securement, in some examples the removable securement may be configured to break in a controlled manner so that a small portion (e.g., the portion embedded in the bone) is left behind, while the rest of the removable securement is removed. For example, the removable securement may be configured so that the one or more prongs (posts) are configured to include a frangible (breakable) region along the length, particularly within the distal end region, when force is applied by pulling the tether. In some examples the distal end region of the removable securement is configured to break or otherwise fail, making it easier for the removable securement to be removed from the bone and graft by pulling the tether. In some examples, the flange portion of the removable securement is configured to be removably separated from at least a portion of the one or more prongs (posts).
As mentioned, these methods may be specifically adapted to be a method of repairing a rotator cuff. For example, a method of repairing a rotator cuff may include removing a region of a cortical layer of a humerus to form a decorticated surface; positioning a graft over the decorticated surface; temporarily securing the graft over the decorticated surface using a removeable securement, wherein temporarily securing comprises passing one or more prongs of the removeable securement through the graft and the decorticated surface; suturing a tendon over the graft and at least a portion of the removeable securement using one or more sutures; and removing the removeable securement from between the graft and the tendon, leaving the tendon sutured against the graft.
Passing one or more prongs (posts) of the removeable securement through the decorticated surface may comprise creating one or more marrow vents within the humerus that access underlying fluid marrow material, wherein the one or more prongs reside within the one or more marrow vents.
Removing the removeable securement may include removing the one or more prongs of the removeable securement from the decorticated surface, thereby causing the fluid marrow material to exit the one or more marrow vents and seep into the graft.
Removing the removeable securement may comprise removing the one or more prongs from the decorticated surface by pulling a tether attached to a flange portion of the removeable securement, wherein the one or more prongs extend from the flange. Pulling the tether may include pulling the tether in a non-perpendicular direction with respect to a long axis of the one or more prongs. Pulling the tether may cause the removeable securement to pivot such that the one or more prongs exit corresponding one or more opening within the decorticated surface.
The methods may further include forming microfractures in the decorticated surface. Such microfractures may be in addition to microfractures created by inserting the removeable securement.
Securing the graft may include anchoring the one or more tendon-securing sutures to the humerus and crossing the one or more tendon-securing sutures over the tendon.
The graft may include a first layer of demineralized bone and a second layer of mineralized bone that is continuously adjacent to the first layer, wherein positioning the graft over the decorticated surface comprises contacting the second layer with the decorticated surface. Securing the tendon against the graft may include securing the tendon against the first layer of the graft.
Suturing the tendon may include suturing the tendons of one or more of: the supraspinatus muscle, infraspinatus muscle teres minor muscle or the subscapularis muscle.
In some examples, a removable securement delivery tool comprises: a handle; and an elongate body attached to a handle, a distal end of the elongate body including a delivery portion configured to deliver a removeable securement in a bone, wherein the deliver portion includes one or more pins adapted to fit through and engage with one or more tubular posts of the removeable securement, each of the one or more pins including a sharp distal tip configured to penetrate bone and create a microfracture hole within the bone, wherein the delivery portion is adapted to release the removeable securement such that the one or more tubular posts of the removeable securement remain within the one or more microfracture holes.
The delivery portion may include an engagement surface that is adapted to engage with a flange portion of the removeable securement. The one or more pins may be configured to translate within the elongate body and relative to the engagement surface. A side of the elongate body may include a recessed channel configured to accommodate a suture attached to removeable securement. The delivery portion may include one pin adapted to fit through and engage with one tubular post of the removeable securement. The delivery portion may include two pins adapted to fit through and engage with two tubular posts of the removeable securement.
In some examples, a removeable securement adapted for use during a rotator cuff repair procedure is described. The removeable securement comprises: a flange having a substantially flat cross section, the flange including opening with a suture looped therethrough; and one or more posts extending from the flange, each of the one or more posts having a central opening extending therethrough.
Each of the one or more posts may include a tapered distal end. The flange may have a U-shaped, wherein the openings are within an apex region of the U-shaped flange. A thickness of the flange may be less than about 1 mm. Each of the one or more posts may have a length ranging from about 2 mm to 10 mm. Each of the one or more posts may have a diameter ranging from about 0.8 mm and 1.5 mm. The suture may be made of a synthetic non-absorbable material and has a diameter ranging from about 0.01 mm and 0.8 mm.
Suturing the tendon against the graft may comprise suturing with the one or more sutures. Suturing the tendon may comprise suturing the tendons of one or more of: the supraspinatus muscle, infraspinatus muscle teres minor muscle or the subscapularis muscle.
Passing the one or more sutures through the thickness of the graft may comprise passing the one or more suture through holes pre-formed through the graft. Alternatively or additionally, the grafts may permit a needle to be passed through the graft without requiring a pre-formed hole.
One innovative aspect of the subject matter described in this disclosure may be implemented as an apparatus for delivering implant material percutaneously to a patient. The apparatus may include an applicator handle, a shaft coupled to and extending distally away from the applicator handle, a needle enclosed within the shaft extending distally away from the applicator handle and protruding from a distal face of the shaft, and a cannula movably coupled to the shaft and configured to receive implant material, wherein relative motion between the shaft and the cannula causes the implant material to push out of the cannula.
In some examples, the distal face of the shaft may be configured to contact the implant material within the cannula. In some other examples, the needle may be configured to extend into the implant material. Furthermore, the needle may be configured to extend from the distal face of the shaft by an adjustable amount.
In some examples, the needle may be configured to extend into the implant material by an adjustable amount. The cannula of the apparatus may include a slot to receive the implant material. In some examples, the cannula may include one or more retention cars configured to hold the implant material within the cannula.
In some examples, the cannula may include one or more grooves configured to receive the shaft. In some other examples, the apparatus may include an extension arm configured to extend through the cannula. The extension arm may be configured to couple with the applicator handle.
Another innovative aspect of the subject matter described in this disclosure may include a method for delivering implant material into an implant region. The method may include inserting a cannula into a patient, wherein a distal end of the cannula is positioned near the implant region, and placing the implant material within the cannula, engaging a shaft of an applicator into the cannula. The method may further include extending a needle from a distal face of the shaft into the implant material and pushing the implant material out of the cannula and into the implant region.
In some examples, engaging the shaft may include contacting the implant material with a distal face of the shaft. In some other examples, pushing the implant material may include moving the shaft into the cannula.
In some examples, inserting the cannula into the patient may include inserting an obturator into the cannula. In some other examples, the method may include inserting an extension arm with the shaft through the cannula. In some cases, the extension arm may manipulate the implant material.
In some examples, the method may include withdrawing the needle and the shaft from the cannula. In some other examples, the method may include extending the needle approximately half way through the implant material.
Another innovative aspect of the subject matter described in this disclosure may include an apparatus for delivering implant material percutaneously to a patient. The apparatus may include a handle, a shaft coupled to and extending distally from the handle, and a plurality of engagement jaws configured to extend through the shaft and protrude from a distal face of the shaft and engage with implant material proximate to the distal face of the shaft.
In some examples, the handle of the apparatus may be configured to receive the plurality of engagement jaws. In some other examples, each engagement jaw may include a grip configured to provide a surface for a clinician to control the engagement jaw, an end configured to engage with the implant material, and a rod configured to couple the end to the grip. In still other examples, the plurality of the engagement jaws may be configured to be removed from the shaft.
The plurality of engagement jaws of the apparatus may include at least a first engagement jaw and a second engagement jaw. An end of the first engagement jaw may include a plurality of rods arranged in a plane to engage with the implant material and an end of the second engagement jaw may include a single rod to engage with the implant material. In some examples, the handle of the apparatus may be at least one of a cylindrical handle, a pistol-grip handle, or a t-handle.
Another innovative aspect of the subject matter described in this disclosure may include a method for delivering implant material into an implant region. The method may include inserting a cannula into a patient, where a distal end of the cannula is positioned near the implant region and placing the implant material onto first and second engagement jaws of an applicator, where the engagement jaws extend beyond a face of a shaft. The method may further include inserting, with the first and second of engagement jaws, the implant material through the cannula, removing the first engagement jaw from the implant material, and affixing the implant material to the patient.
In some examples, removing the first engagement jaw from the implant material may include moving a grip coupled to the first engagement jaw proximally away from the face of the shaft. In some examples, the shaft may be coupled to the handle and the shaft may extend distally away from the handle.
In some examples, the second engagement jaw may include a plurality of rods arranged in a plane. The second engagement jaw may provide pressure to the implant material while the implant material is being affixed to the patient.
Another innovative aspect of the subject matter described in this disclosure may include a transiently liquid-tight cannula system that includes a cannula having a proximal end and a distal end, a removable dam assembly configured to thread onto the proximal end of the cannula and resist liquid flow through the cannula, and a removable obturator configured to pass through the removable dam, extend and protrude through the distal end of the cannula.
In some cannula systems the removable obturator may be configured to detachably engage with the removable dam assembly and apply a twisting motion through the removable dam assembly to the cannula.
Any of the cannulas described herein may include threads configured to draw the cannula into a patient when a twisting motion is applied to the cannula. Furthermore, any of the cannulas described herein may include a threaded section configured to engage with and attach to the removable dam assembly.
In some cannula systems, the removable dam assembly may include a conforming gasket configured to resist liquid flow and an engagement surface configured to detachably engage with the removable obturator. The conforming gasket may be configured to allow the removable obturator to pass therethrough.
In various cannula systems, the removable obturator may include a handle and the engagement surface of the removable obturator may be distal with respect to the handle. A distal end of the removable obturator may be conically shaped.
Another innovative aspect of the subject matter described in this disclosure may include a method that includes inserting a cannula system into a surgical portal, where the cannula system includes a cannula having a proximal end and a distal end, a removable dam assembly configured to thread onto the proximal end of the cannula and resist liquid flow through the cannula, and an obturator configured to pass through the removable dam assembly, extend and protrude through the distal end of the cannula. The method may further include removing the obturator, inserting implant material through the cannula into an implantation area, and affixing the implant material to a patient.
In some examples, the method may further include removing the removable dam assembly from the cannula prior to inserting the implant material through the cannula. Furthermore, the method may include inserting the implant material through the removable dam assembly and re-attaching the removable dam assembly to the cannula.
Various removable dam assemblies may include an engagement surface configured to detachably engage with the engagement surface of the obturator. In some examples of the method, inserting the cannula may include twisting the obturator to cause the cannula to be drawn through the surgical portal. In some examples, the cannula system may be configured to resist liquid flow after the obturator is removed.
Another innovative aspect of the subject matter described in this disclosure may include another transiently liquid-tight cannula system that includes a splitable cannula having a proximal end and a distal end and a removable obturator configured to form a liquid-tight scal with the splitable cannula, wherein the proximal end of the splitable cannula is configured to receive the removable obturator.
In some aspects, the cannula system may include a removable fixation configured to temporarily hold together the splitable cannula.
In some examples, the distal end of the splitable cannula is configured to be inserted into an implantable access portal. In some further examples, the splitable cannula may be configured to receive an applicator and implant material while inserted into the implantable access portal.
In some other examples, the splitable cannula may be configured to separate into two or more pieces to facilitate removal from an applicator while the applicator is inserted through the splitable cannula and an implantable access portal.
In still other examples, the splitable cannula may include at least a first member and a second member and the first member and the second member include locking features to detachably couple the first member to the second member.
Another innovative aspect of the subject matter described in this disclosure may include a method that includes inserting a splitable cannula system into an implantable access portal, where the splitable cannula system includes a splitable cannula having a proximal end and a distal end, a fixation device configured to temporarily hold the splitable cannula together, and an obturator configured to pass through the splitable cannula. The method may further include removing the obturator from the splitable cannula system, inserting a delivery system holding implant material through the splitable cannula and the implantable access portal into an implantation area, and removing the splitable cannula from the implantable portal.
In some examples, removing the splitable cannula may include separating the splitable cannula into two or more sections while the delivery system remains within the implantable access portal. In some other examples, removing the splitable cannula may include overcoming the fixation device to separate the splitable cannula into two or more sections.
In some examples, removing the splitable cannula may include grasping the distal end of the splitable cannula and moving the splitable cannula in a proximal direction.
In some examples, the disclosed methods may include affixing the implant material to the implantation area.
All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.
A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:
Described herein are methods, devices and systems for delivering and securing a graft implant to tissue (e.g., bone) during a surgical procedure. The methods and tools are well suited for delivering and implanting connective tissue-to-bone interface grafts that are surgically implanted onto bone to allow ingrowth of both bone and connective tissue. These methods and tools particularly well adapted for implantation and securement as part of a minimally invasive, e.g., arthroscopic, laparoscopic, surgery.
Example connective tissue-to-bone interface grafts may include a demineralized porous structure that can act as a scaffold for cellular attachment and proliferation. In some examples, the graft has a layered structure including at least two layers, such as a demineralized layer and a mineralized layer. Examples of such grafts (e.g., scaffolds) are described in U.S. patent application Ser. No. 17/015,043, which is incorporated herein by reference in its entirety.
The graft may be shaped and sized so that it may be inserted or implanted into the body, as will be described in greater detail below, as well as providing optimal attachment to the bone and connective tissue. In the example shown in
In some examples, the grafts may comprise a collagen-based porous network capable of guiding tissue differentiation that can be used to regrow damaged soft tissues (e.g., connective tissue). The relatively high porosity, e.g., of either or both the demineralized and mineralized material may allow host integration, regeneration of relatively large sections of tissue, and vascularization. The collagen-based porous structure may allow binding of a variety of factors to the trabecular (pores) within the graft formed of bone. Additional materials, such as hydrogels or extracellular matrix material, and/or a variety of biological components and therapeutic compounds may be integrated within the graft. The grafts may contain collagen trabecular that may allow the structure to maintain a pre-defined shape and maintain nutrient transport. Thus, the grafts may desirably provide mechanical integrity, nutrient transport during tissue regeneration, differentiation of well-defined cell populations, vascularization.
As used herein, the term “biocompatible” may refer to any material having a relatively low risk of provoking an adverse response when introduced in a mammal, in particular a human patient. For example, a suitable biocompatible material when introduced into a human patient has relatively low immunogenicity and toxicity. The term “demineralized” may refer to bone from which a substantial portion of minerals natively associated with the bone minerals have been removed. The term “demineralized bone” is intended to refer to any bone, including cortical and/or cancellous bone, from any source including autologous, allogeneic and/or xenogeneic bone, that has been demineralized to contain, in certain examples, less than about 8 wt % residual calcium (e.g., less than about 7 wt % residual calcium, less than about 6 wt % residual calcium, less than about 5 wt % residual calcium, less than about 4 wt % residual calcium, less than about 3 wt % residual calcium, less than about 2 wt % residual calcium, or less than about 1 wt % residual calcium, etc.).
A graft may be referred to as “substantially free of mineralized bone” when all of the bone within the graft has been exposed to demineralizing conditions and is at least partially demineralized. Graft that are substantially free of mineralized bone are structurally and functionally distinct from grafts made from bone that has been masked prior to demineralization (see, e.g., U.S. Published Application 20110066241).
In certain examples, the surface structure of the graft may be modified to provide texture, roughness and/or three-dimensional unevenness to the graft. The surface roughness of the graft may be altered by chemical etching or by physical etching. The grafts described herein may also be used as delivery devices for therapeutics, wherein the therapeutic comprises the minced tissue, which may include a combination of cells, extracellular matrix and/or inherent growth factors. The graft may thus permit hormones and proteins to be released into the surrounding environment.
The graft may be useful in treating injuries involving interfaces within connective tissues. The major applications include repair of ligaments, tendons, and cartilage. Ligaments are dense bands of connective tissue composed primarily of type I collagen that connect bones to other bones. Ligaments function as motion guides and joint motion restrictors. At all articulating joints (neck, spine, shoulder, elbow, wrist, hip, knee, ankle) in the body, these tissues are placed under constant dynamic loading. An injury known as a sprain results when the ligaments are stretched, and in some cases, stretched severely enough to be torn. While in some cases, ligament tears can heal on their own, other cases show a lack of inherent healing capacity. If left untreated or if treated improperly, ligament tears can lead to chronic disability including arthritis at the affected joint. Tendons, like ligaments, are dense collagenous tissues found at every articulating joint in the body. Tendons, however, connect muscles to bone, allowing the force produced by the muscles to be translated into motion. When overloaded, tendons are at risk for tearing and in some cases require surgical replacement to return joint motion and prevent muscle atrophy.
According to some examples, the graft is implanted and held in place at an implant site by an anchoring and suturing system.
It may be beneficial to complete the procedure without leaving any attachment materials (surgical materials) between the graft and the bone and/or between the graft and the tendon. In particular, it may be beneficial to allow the graft to be held between the tendon and the bone only by the tendon attachment. This may enhance healing.
For example, the graft may be temporarily secured to the bone by a temporary removeable securement prior to and/or during suture and securement of the tendon or ligament to the bone. The temporary removeable securement may have a form factor and size that prevent it from interfering with suturing of the tendon (e.g., double arrow cuff repair). Once the tendon or ligament is sutured and secured to the bone, the secured tendon or ligament can provide a compression force on the graft that is sufficient to prevent the graft from migration. Thus, the temporary removeable securement can be extracorporeally removed, thereby minimizing concerns of foreign body response or tissue damage resulting from a long-term implanted component within or near the biological graft.
In some examples, the temporary removeable securement includes one or more pins or needles (e.g., 18-gauge needles) that are percutaneously deployed through the graft and into the decorticated cancellous bone. The lateral anchors can then be placed, the percutaneous needles removed, and the tendon or ligament surgically sutured and repaired as usual.
In some examples, the temporary removeable securement is any suitable atraumatic arthroscopic tool. The atraumatic arthroscopic tool can be manipulated to hold the graft in place over the graft site while medial anchors are passed through the graft. Then the tendon or ligament can be surgically sutured and repaired as usual.
In some examples, the temporary removeable securement is configured to pass through the graft and through one or more holes formed in the underlying bone.
The material of the removeable securement may vary. In some examples, the temporary removeable securement is made of a shape memory material (e.g., Nitinol). In some examples, the removeable securement may be configured to create an outward force at the prongs that retains the device within retention holes within the bone. In one example, the removeable securement is heat set such that the prongs have a width greater than the body (e.g., >5 mm). When released from a delivery system, the removeable securement device may attempt to revert to the wider configuration, thereby placing an outward force on the anterior face of an anterior retention hole and outward force on the posterior face of a posterior retention hole.
Alternatively or additionally, the removeable securement may include a polymeric material. In some examples, the polymeric material may be configured to collapse and expand to provide an interference fit within the retention holes within the bone. For example, the device may include an expandable/collapsible balloon or a thin-walled tube. In some cases, the device includes a polymeric clip that is inserted on an angle to impinge with walls in the retention hole.
Once the tendon is sutured and at least partially secured, the retaining device is no longer needed and can be removed. This can be done by pulling a tether attached to the removeable securement body in a non-parallel direction with respect to the flat removeable securement body (e.g., down), as accommodated by the curvature of the bone and surrounding anatomical structure. This can cause the device to pivot/rotate to an extent that the prongs are released from the retention holes. Upon further pulling of the tether, the removeable securement can be removed from between the graft and the tendon and removed from the patient's body. It should be noted that other removal “handles” could be placed indwelling instead of, or in addition to, the tether. In one example, a short tether (e.g., <1 inch) or a handle that is amenable to being firmly gripped by arthroscopic graspers may be implemented. In some cases the removable securement device may be removed when the tendon is partially secured (leaving room for removal); the tending may be completely fixed down, securing the graft, after removing the removable securement device. In some examples, the removable securement device may be removed after the tendon is secured.
As described above, the prongs of the removeable securement may be retained within retention holes formed within the bone. In some cases, the retention holes may be sufficiently deep to reach the marrow material and blood. Once the removeable securement is removed, the marrow material can seep into the repair site, including the graft, providing a therapeutic benefit and promote healing by increasing native growth factors and stem cells at the repair site. In this way, the retention holes may not only retain the removeable securement but also serve to improve the surgical outcome. Such marrow venting may be used in place of a separate marrow venting procedure (e.g., microfracture procedure), which could add to the procedure costs. Alternatively, a separate marrow venting procedure (e.g., microfracture procedure) may be implemented in addition to forming the retention holes for the removeable securement.
The removeable securement 400 may be made of any of a number of materials. In some examples, the device 400 is made of a biocompatible polymer and/or metal material. In some cases, the device 400 is made of a shape memory alloy (e.g., nitinol).
The dimensions of the device 500 may vary. In some examples, the prongs 502a and 502b have lengths ranging from about 4 mm and 8 mm. In some examples, the diameter of the prongs 502a and 502b range from about 0.8 mm and 1.5 mm. In some examples, a thickness of the flange 504 may range from about 0.25 mm and 1 mm. In some examples, the thickness of the flange 504 is based on a predicted height above the bone set by the maximum height of the compressed graft (e.g., 3 mm or less above the bone).
Similar to device 400, the removeable securement 500 may be made of any of a number of materials. In some examples, the device 500 is made of a biocompatible polymer and/or metal material. In some cases, the device 500 is made of a shape memory alloy (e.g., nitinol).
Any of the removeable securement insertion tools may include various features to facilitate delivery of the removeable securement to the delivery site and/or create sufficiently deep holes within the bone to access bone marrow material. In some examples, the removeable securement insertion tool includes an adjustable head and cannula (e.g., 10 mm cannula) with a pushability within a certain distance (e.g., 9 mm). In some cases, the removeable securement insertion tool includes a drive mechanism similar to a stapler or riveter to drive the removeable securement into the bone, which can allow for easy insertion and removal of the tool. In some cases, the removeable securement insertion tool can allow for deployment in non-decorticated cortical bone.
The elongate body of the removeable securement insertion tool may have one or more bends to facilitate access to the puncture sites of the bones.
The removeable securement 700 includes a tether 748 that loops through the removeable securement 700, as described herein. In some cases, proximal ends of the tether 748 extend extracorporeally. The tether 748 should have sufficient tensile strength to resist breakage when pulled on during removal of the removeable securement 700. The tether 748 may be made of any suitable material. In some cases, the tether is made of a synthetic non-absorbable material and have a diameter ranging from about 0.01 mm and 0.8 mm.
In some examples, the prongs 702a and 702b are inserted using a removeable securement insertion tool (e.g., tool 550) such that the holes through the bone are sufficiently deep to provide marrow venting. Thus, such holes can serve as marrow vents and retention holes for the prongs 702a and 702b of the removeable securement 700. In some examples, the diameters of the marrow vents range from about 0.8 and 1.5 mm. The depth of the marrow vents may vary depending, for example, how deep the decorticated surface 740 was made. In some instances, 1 mm deep holes are adequate for marrow venting. In some instances, the holes may be deeper, e.g., ranging from about 8 mm and 12 mm. In some cases, the marrow vents have depths that are greater than the length of the prongs 702a and 702b of the removeable securement 700.
At
Once the tendon 749 is sufficiently sutured in place, the tether 748 can be pulled to remove the temporary removeable securement 700 from under the tendon 749, as shown in
It should be noted that the procedure sequence presented in
Any suture securement technique may be used to secure a graft under a tendon/ligament as described herein. For example,
In any of the methods described herein both the graft and the region to be repaired may be prepared at the beginning of the procedure. For example, in any of these methods, the graft may be hydrated before implanting into the body. For example,
The bone surface may then be prepared, e.g., by decorticating the region onto which the graft is to be applied.
The implant delivery system 1100 may be used to deliver implant material percutaneously to a patient. For example, the implant delivery system 1100 may be used to deliver and guide implant material into any region, including any feasible arthroscopic space. The implant material can be any feasible implant material. In some examples, the implant material can be a graft and/or a bone graft material that includes a layers of mineralized and demineralized material. The implant material may be porous, and in some cases different layers of the implant material may have different porosities. In some examples, the bone graft material may be configured to permit migration of bone marrow into the demineralized layer. In some other examples, the implant delivery system 1100 may guide and deliver bone graft material into the shoulder area to repair a rotator cuff.
The cannula 1120 may be separated from the applicator handle 1110 by, for example, sliding the cannula 1120 on the shaft 1112 distally (e.g., away from) the applicator handle 1110. When the cannula 1120 is separate from the applicator handle 1110, the cannula 1120 may be inserted into the patient. Following insertion, the implant material may be placed into (loaded) into the cannula 1120 and the shaft 1112 re-coupled to the cannula 1120.
As the shaft 1112 is inserted into the cannula 1120, the needle 1114, which may protrude from the distal end of the shaft 1112, may penetrate and engage with the implant material. The needle 1114 may be enclosed and/or surrounded by the shaft 1112. Thus, the needle 1114 in combination with the shaft 1112 may be used to guide the implant material through the cannula 1120. In some examples, a clinician may guide the implant material into the arthroscopic space by manipulating the applicator handle 1110, shaft 1112, needle 1114, and/or the cannula 1120. In some cases, after delivery of the implant material to the implant region, the clinician may use the applicator handle 1110 to stabilize the implant material prior to and in some cases during fixation. Implantation and fixation of the implant material is described in more detail below in conjunction with
As described with respect to
The shaft 1212 may be coupled to the handgrip 1210. The shaft 1212 may be rigid, partially rigid, or flexible. The shaft 1212 may be any feasible length and may be configured to slidably couple to the cannula. The shaft 1212 may extend distally away from the handgrip 1210. Thus, the shaft 1212 may be smooth and include features (rails, ridges, protrusions, or other feasible characteristics) to movably couple with the cannula. When the cannula is movably coupled to the shaft 1212, the clinician may control the applicator handle and cannula through the handgrip 1210.
The needle 1220 may traverse the length of the handgrip 1210 and the shaft 1212. As shown, a tip of the needle 1220 may extend from a distal (with respect to the handgrip 1210) end of the shaft 1212. A proximal end of the needle 1220 may include a needle controller 1225.
In some examples, the needle 220 may be flexible and may slide within the shaft 1212. For example, the needle 1220 may slide proximally and distally within the shaft 1212. In some cases, the clinician can control the amount of needle 1220 extending beyond the shaft 1212 by moving the needle controller 1225 either proximally or distally. The needle 1220 may be used to extend, at least partially, into implant material that may be positioned at a distal end of the shaft 1212. In some examples, the clinician can adjust the needle 1220 to be inserted approximately half way through the implant material. In some other examples, the needle 1220 may extend any feasible amount through the implant material. In this manner, the needle 1220 may be used to control positioning and placement of the implant material, particularly as the implant material is placed and fixated within a patient. In some examples, use of the needle 1220 may be optional.
The extension arm 1230 may be movably coupled to the handgrip 1210. In some cases, the extension arm 1230 may be inserted into the handgrip 1210 before or after the shaft 1212 is inserted into the cannula. Thus, the extension arm 1230 may be inserted with the shaft 1212 into the cannula. In some other cases, the extension arm 1230 may be inserted within the handgrip 1210 while being partially withdrawn. During implantation, the clinician may load implant material into the cannula push the handgrip 1210 and the shaft 1212 distally into the cannula. The motion of the shaft 1212 relative to the cannula can deploy and deliver the implant material from the cannula and into the patient. If the clinician has positioned a distal portion of the cannula near or within an arthroscopic space, then the clinician can deliver the implant material to the arthroscopic space. After the implant material has been deployed from the cannula, the clinician may push the extension arm controller 1235 distally causing a distal end of the extension arm 1230 to extend beyond the distal end of the shaft 1212. The distal end of the extension arm 1230 may be used to apply pressure to or otherwise position the implant material and thereby assist in fixating the implant material.
In some examples, the cannula 1300 may include threads 1320 that may be affixed, attached, or in some cases molded onto the body of the cannula 1300. The threads 1320 may assist in the insertion of the cannula 1300 into the patient. For example, the clinician may twist the cannula 1300 enabling the threads 1320 to draw the cannula 1300 into the patient. The inner surface of the cannula 1300 may be smooth to facilitate smooth insertion and deployment of the implant material. The smooth inner surface may also enable the shaft of the applicator handle (not shown) to slide within the cannula 1300, The outer surface of the cannula 1300 may also be smooth. In some examples, the outer surface of the cannula 1300 may be textured to enable manipulation by the clinician, particularly during insertion of the cannula 1300. The texture finish may be achieved by diamond buffing, by abrasion with an abrasive such as sand paper or grit stone, and in some cases by bead blasting.
The cannula 1300 may be formed of any feasible material. In some cases, the cannula 1300 may be formed from impact resistant polymer that may be autoclavable. In some examples, the cannula 1300 and the obturator 1310 may be disposable or reusable.
After the implant material has been placed into the cannula 1500, the shaft portion of the applicator handle (not shown) may be inserted into the cannula. In some examples, the shaft grooves 1520-1522 may receive and/or engage with one or more features of the shaft. For example, the shaft may include rails, ridges, protrusions or the like that may be molded, affixed, or otherwise integrated into the shaft. Thus, the grooves 1520-1522 may enable the shaft to be movably coupled to the cannula 1500 and thereby guide the shaft through the cannula 1500. In some examples, the distal end of the shaft may engage with or contact the implant material. Thus, by moving the shaft distally relative to the cannula 1500, the implant material may be ejected or deployed from the cannula 1500. The distal end of the cannula 1500 may be positioned into the arthroscopic area by the clinician. Thus, the implant material may be moved from the cannula 1500 into a graft area that has be prepared to receive the implant material.
The cannula 1500 may be used for delivery of the implant material 1550 into any feasible patient area including, without limitation, arthroscopic areas such as rotator cuff areas. If the cannula 1500 (for example, in conjunction with the implant delivery system 1100 of
As described above with respect to
In some cases, the distal face of the shaft 1700 may move the implant material through the cannula and into position within the patient. The clinician may cause the extension arm 1720 to move distally along the shaft 1700. As shown, the extension arm 1720 may extend beyond the distal face of the shaft 1700. In this manner, a distal portion of the extension arm 1720 may be placed in contact with the implant material. In some examples, the extension arm 1720 may be used to at least temporarily hold or apply pressure to the implant material while other implements or tools suture or otherwise affix the implant material to the patient. After the implant material is affixed to the patient, the extension arm 1720, needle 1710 and shaft may be withdrawn from the patient. The cannula may also be withdrawn. Width of a distal end of the extension arm may be comparable to, or associated with the distal face of the shaft 1700. An example width may be 9 millimeters (mm), however any feasible width is contemplated.
The method 1800 begins in block 1802 as the cannula 1120 is inserted into the patient. For example, if implant material is bone graft material to be used in rotator cuff repair, then the clinician may insert the cannula 1120 through a lateral portal in the shoulder. In some other examples, the clinician may insert the cannula 1120 through the back or front (chest) of the patient.
In block 1803, an obturator (such as the obturator 1310 of
In block 1804, the clinician may load (place) implant material into the cannula. For example, the clinician can insert the implant material, which may be bone graft material, through a slot in the cannula 1120.
In block 1806, the clinician may engage the applicator handle 1110 with the cannula 1120. For example, a shaft 1112 of the applicator handle 1110 may be placed within the cannula 1120. In some cases, as the shaft 1112 enters the cannula 1120, a distal end of the shaft 1112 may contact the implant material. The implant material may move distally within the cannula 1120.
In block 1807, the clinician may optionally insert the needle 1114 into the implant material. For example, the clinician may manipulate a needle controller to insert the needle 1114 approximately half way through the implant material. If the implant material is 15 millimeters (mm) in length, then the clinician may insert the needle 1114 about 7.5 mm into the implant material. Any other needle insertion depths are possible. The needle 1114 may provide the clinician more control of the implant material through the applicator handle 1110 and the shaft 1112.
In block 1808, the clinician may push out the implant material from the cannula 1120. For example, the clinician may push the shaft 1112 distally with respect to the cannula 1120. This distal motion may cause a distal face of the shaft 1112 to push out the implant material from the cannula 1120 and into the patient.
In block 1810, the clinician may optionally operate the extension arm (such as the extension arm 1720 of
In block 1812, the clinician may affix the implant material to the patient. In some examples, the clinician may suture the implant material to any feasible anatomical structure within the patient.
The handle 1910 may be coupled to the shaft 1920. The shaft 1920 may be rigid, partially rigid, or flexible. The shaft 1920 may extend distally from the handle 1910. The handle 1910 and the shaft 1920 may include openings and/or holes that enable the engagement jaws 1930 and 1930 to traverse the implant delivery system 1900. For example, the engagement jaw 1930 may be inserted into a first opening on the handle 1910 that is coupled to a first hole through the shaft 1920. Similarly, the engagement jaw 1931 may be inserted into a second opening on the handle 1910 that is coupled to a second hole through the shaft 1920. As the engagement jaws 1930 and 1931 are inserted into the handle 1910 and through the shaft 1920, respective ends of the engagement jaws 1930 and 1931 may protrude from (e.g., extend beyond) a distal face of the shaft 1920.
Implant material may be attached to (engage with) the ends of the engagement jaws 1930 and 1931. The implant delivery system 1900 may then be used to guide the implant material to the implant region. In some examples, the implant delivery system 1900 may be used to guide the implant material through a cannula to the implant region.
After the implant material has been placed in the implant region, the clinician may withdraw one of the engagement jaws 1930 or 1931 from the implant material. The implant material may then be affixed (in some cases sutured) to the patient. The single engagement jaw within the implant material may be used to stabilize and/or position the implant material. After the implant material has been affixed to the patient, the remaining engagement jaw 1930 or 1931 may be withdrawn from the implant material.
The grips 2002 and 2012 may be formed from any feasible material. In some cases, at least a portion of the grips 2002 and 2012 may include textured or grooved features to provide feasible surface for the clinician to manipulate the rods 2006 and 2016, respectively.
The rods 2006 and 2016 may be rigid or flexible. In some cases, the rods 2006 and 2016 may be formed from a flexible metal such as Nitinol. The ends 2004 and 2014 may be distally located on the rods 2006 and 2016 with respect to grips 2002 and 2012, respectively. In some examples, the cross section of the ends 2004 and 2014 may be circular, flat, square, rectangular, ellipsoidal, trapezoidal, or any other feasible shape. The engagement jaws 2000 and 2010 may be inserted into, and be movably coupled to the shaft 1920 of
As described above, one of the jaws associated with the implant delivery system 2100 may be moved or removed. For example, a clinician can move a grip of an engagement jaw proximally away from a distal face of the shaft 2120. The remaining engagement jaw 2130 may enable the clinician to maintain control of the implant material while the implant or anatomy near the implant region are being manipulated to affix the implant material. Advantageously, removal of an engagement jaw from the shaft 2120 retracts the engagement jaw proximally from the implant material. That is, the implant delivery system 2100 may not impart any radial (with respect to a center of the shaft 2120) motion to the implant material when one or more of the engagement jaws are retracted. Lack of radial movement may allow the clinician to better control movement and placement of the implant material while being affixed.
The method 2200 begins in block 2202 as the cannula is inserted into the patient. For example, if implant material is bone graft material to be used in rotator cuff repair, then the clinician may insert the cannula through a lateral portal in the shoulder. In some other examples, the clinician may insert the cannula through the back or front (chest) of the patient.
In block 2203, an obturator may optionally be used with the cannula to aid in the insertion of the cannula. This optional step is illustrated with dashed lines in
In block 2204, the clinician places or attaches implant material onto the engagement jaws 1930 and 1931 of the implant delivery system 1900. In some examples, the engagement jaws may extend distally away from the handle 1910 and beyond the shaft 1920. Thus, the clinician may attach the implant material to the engagement jaws 1930 and 1931 that extend beyond the shaft 1920.
In block 2206, the clinician inserts the implant material into the patient through the cannula. In some examples, the clinician may place a distal end of the cannula into an implant region. Thus, as the clinician inserts the implant material through the cannula, the implant material may be near the region of the patient that has been prepared to receive the implant.
Next, in block 2208 the clinician withdraws one engagement jaw from the implant material. For example, the clinician may draw engagement jaw 1931 (by pulling or otherwise moving the engagement jaw 1931 proximally away from the implant material). In some cases, the clinician may press or actuate a grip, such as the grip 2012 shown in
Next, in block 2210, the clinician affixes the implant material to the patient. In some cases, the clinician may suture or otherwise attach the implant material to any feasible structure or anatomy of the patient to affix the implant material. Advantageously, the implant delivery system 1900 may be used to control movement and/or placement of the implant material while the implant material is being affixed to the patient. In some cases, the clinician can control the implant material through the remaining engagement jaw in the implant delivery system 1900.
In block 2212, the clinician withdraws the implant delivery system 1900 from the patient. Since the implant material has been affixed in block 2210, the implant material is stable and the implant delivery system 1900 may be withdrawn.
The engagement jaws 2330 and 2340 may be similar to the engagement jaws shown in
A clinician may cause either or both engagement jaws 2330 and 2340 to withdraw into the shaft 2320 simply by pulling the grip 2335 and/or 2345 proximally (toward the clinician). In some cases, the clinician may remove a complete grip/rod/engagement jaw assembly from the handle 2310.
Similar to the implant delivery system 1900 of
After the implant material has been placed in the implant region, the clinician may withdraw one of the engagement jaws 2330 or 2340 from the implant material. The implant material may then be affixed (in some cases sutured) to the patient. Similar to the applicator handle 1200 of
The handle 2410 may include grips 2435 and 2445. The grip 2435 may be coupled to a rod (not shown) and further coupled to the engagement jaw 2430. Similarly, the grip 2445 may be coupled to a rod (not shown) and further coupled to the engagement jaw 2440.
Implant material may be attached to (engage with) the ends of the engagement jaws 2430 and 2440. The implant delivery system 2400 may then be used to guide the implant material to the implant region. In some examples, the implant delivery system 2300 may be used to guide the implant material through a cannula to the implant region. The clinician may withdraw one of the engagement jaws from the implant region leaving the other engagement jaw to control the position of the implant material while being affixed to the patient. For example, the engagement jaw 2430 may be used to stabilize and/or position the implant material after the engagement jaw 2440 have been withdrawn from the implant region.
The handle 2510 may include grips 2535 and 2545. The grip 2535 may be coupled to a rod (not shown) and further coupled to the engagement jaw 2530. Similarly, the grip 2545 may be coupled to a rod (not shown) and further coupled to the engagement jaw 2540.
Implant material may be attached to (engage with) the ends of the engagement jaws 2530 and 2540. The implant delivery system 2500 may then be used to guide the implant material to the implant region. In some examples, the implant delivery system 2500 may be used to guide the implant material through a cannula to the implant region. The clinician may withdraw one of the engagement jaws from the implant region leaving the other engagement jaw to control the position of the implant material while being affixed to the patient. For example, the engagement jaw 2530 may be used to stabilize and/or position the implant material after the engagement jaw 2540 have been withdrawn from the implant region.
The implant delivery system 2600 may include a handle 2610, a shaft 2620 and engagement jaws 2630 and 2640. The engagement jaw 2630 may be coupled to a rod 2637 which is further coupled to a grip 2635. Similarly, the engagement jaw 2640 may be coupled to a rod 2647 which is further coupled to a grip 2645. In some examples, the rods 2637 and 2647 may be formed from Nitinol, or any other feasible material.
As shown, the first engagement jaw 2710 may be formed of three discrete rods. Other examples may have more or fewer rods. The discrete rods may be arranged in a planar fashion providing a wider surface than a single rod. The wider surface may advantageously provide more control of the implant material while being affixed to the patient. The discrete rods may be coupled to a common rod to make actuation by a common grip feasible. For example, the first engagement jaw 2710 may be coupled to a single rod 2715 that traverses shaft 2730 and is coupled to a grip (not shown).
Another example of an implant delivery apparatus (e.g., configured as an implant delivery system) is shown in
For example,
As shown in the sectional view of
The finger control(s) may be separately actuatable or jointly actuatable, as mentioned. In some example, actuation may move the finger controls distally or proximally relative to the palm grip (or palm support) 3712 portion, sliding the distal engagement jaws distally or proximally. In some examples a bias (e.g., spring, hydraulic, etc.) may be coupled to the finger control to bias the distal engagement jaws either proximally or distally. In some examples the apparatus may be configured to lock the control(s) for the distal engagement jaws in a first configuration (e.g., extended) until released, so that the distal engagement jaws may be securely held, preventing premature release of the implant (until the lock release is selected).
The handle 3712 may include grips.
An exploded view of these elements is shown in
An implant material may be secured or attached to (engage with) between the engagement jaws 3730 and 3740. As shown and as mentioned above, the engagement jaws may be configured as substantially flat, at least on one side. The engagement jaws may be elongate and configured to distribute the force securing the implant within the jaws. The engagement jaws may have the same configuration or may have different configurations. In some examples the engagement jaws may be configured to have a spatula-like body that is flat on at least the side configured to secure to the implant. In some examples the engagement jaw(s) may be rounded or ovoid in cross-section, e.g., forming rods. Thus, in any of these apparatuses, the jaws may be configured to increase contact footprint and arthroscopic security of the implant (e.g., graft).
In the apparatus shown in
In general, the implant delivery system 3700 may be used to guide and position an implant material to and within the implant region. In some examples, the implant delivery system may be used to guide the implant material through a cannula to the implant region. The clinician may withdraw one of the engagement jaws from the implant region leaving the other engagement jaw to control the position of the implant material while being affixed to the patient. For example, the engagement jaw 3730 may be used to stabilize and/or position the implant material after the engagement jaw 3740 have been withdrawn from the implant region.
As mentioned above, any of the apparatuses, including any of the implant delivery apparatuses (which may also be referred to herein as implant delivery systems or implant delivery devices) may be used with any appropriate access port or system, including a cannula system. These apparatuses may be adapted for use with off-the-shelf access ports or cannulas, including those having a valve to prevent release/removal of material from the body through the port or cannula.
Returning now to
The cannula system 2800 may include a cannula 2810, a removable dam assembly 2820, and a removable obturator 2830. The cannula 2810 may generally be cylindrical in shape and have a proximal end (e.g., an end generally near the user, operator, clinician, etc.) and a distal end opposite the proximal end. The removable dam assembly 2820 may be coupled to the proximal end of the cannula 2810. The distal end of the cannula 2810 may include threads 2811 disposed on an outer surface to assist the user in inserting the cannula system 2800 through one or more layers of tissue. For example, the user may twist the removable obturator 2830 causing the cannula 2810 to twist and enabling the threads 2811 to draw the cannula 2810 into the tissue.
The removable obturator 2830 may be inserted through the removable dam assembly 2820 and through the cannula 2810. A distal end of the removable obturator 2830 may have a conical shape. Thus, when the removable obturator 2830 is inserted into the cannula system 2800, the distal end of the removable obturator 2830 may help insert the cannula system 2800 into the patient.
The removable dam assembly 2820 may prevent or reduce fluid loss when the cannula 2810 is inserted into the patient and will be described in more detail in conjunction with
The cannula 2910 may include threads 2911 on a distal end to assist in the insertion and placement of the cannula 2910 with respect to the patient. In addition, the cannula 2910 may include threads 2912 disposed on a proximal end. The threads 2912 may be used to couple or attach the removable dam assembly 2920 to the cannula 2910.
The removable dam assembly 2920 may include a conforming gasket 2922, an engagement surface 2924, and a housing 2926. The housing 2926 may include threads (not shown) to engage with the threads 2912 on the cannula 2910. In this manner, the removable dam assembly 2920 may be attached to the cannula 2910. In addition, the housing 2926 may receive the conforming gasket 2922 and the engagement surface 2924. The conforming gasket 2922 may act as a barrier to prevent or reduce fluid loss through the cannula system 2900 when inserted in a patient. For example, when the removable dam assembly 2920 is affixed to the cannula 2910, the conforming gasket 2922 may block the flow of fluids through the cannula 2910. In some examples, the removable obturator 2930 may pierce the conforming gasket 2922. The conforming gasket 2922 may continue to provide a liquid-tight seal, even with the removable obturator 2930 in place. The conforming gasket 2922 may be formed from rubber, vinyl, any polymer, or any other feasible material.
The engagement surface 2924 may hold the conforming gasket 2922 within the housing 2926. In addition, the engagement surface 2924 may provide a surface for the removable obturator 2930 to engage with. In some examples, the removable obturator 2930 may have an engagement surface 2933 distal to the handle 2931. When the removable obturator 2930 is inserted into the cannula system 2900, the engagement surface 2933 may engage with the engagement surface 2924. In this manner, the removable obturator 2930 may be detachably coupled to the removable dam assembly 2920 and the cannula 2910. This coupling (e.g., engagement) allows twisting motion imparted to the handle 2931 to be coupled to the cannula 2910 through the removable dam assembly 2920.
The method 3200 begins in block 3202 as the cannula system 2900 is placed within a surgical portal. For example, the user may create a surgical portal by making an incision on the patient. After the incision is made, a distal end of the cannula system 2900 may be placed on, near, or within the surgical portal. The user may then twist the removable obturator 2930 causing the cannula 2910 to rotate and draw the cannula system 2900 into the surgical portal.
Next, in block 3204 the removable obturator 2930 is removed from the cannula 2910. Removal of the removable obturator 2930 leaves the removable dam assembly 2920 affixed to the cannula 2910 thereby providing a liquid-tight seal for the cannula system 2900.
Next, in block 3206 the removable dam assembly 2920 is removed from the cannula 2910. In block 3208 an implant delivery system is inserted through the removable dam assembly 2920. For example, engagement jaws configured to hold implant material may be inserted through the removable dam assembly 2920. In some cases, the engagement jaws may be inserted through the conforming gasket 2922. In block 3210 implant material may be attached or affixed to the implant delivery system. In some examples, the implant material may be attached to engagement jaws protruding form an end of a shaft of the implant delivery system.
Next, in block 3212 the implant delivery system and the implant material may be inserted through the cannula 2910. In block 3214, the removable dam assembly 2920 is re-attached to the cannula 2910. Reattachment of the removable dam assembly 2920 reestablishes a liquid-tight seal to the cannula 2910. Next, in block 3216 the user can attach the implant material to the patient.
The splitable cannula system 3300 may include a splitable cannula 3310, a removable fixation 3320, and a removable obturator 3230. The splitable cannula 3310 may be used to provide a cylindrical opening or tube for use with an implant delivery system (sometimes referred to as an applicator). In addition, the splitable cannula 3310 may separate into a number of pieces to allow removal of the splitable cannula 3310 while in used with the implant delivery system. The splitable cannula 3310 may include a distal end 3311 and a proximal end 3312. The distal end 3311 may inserted into a patient, in some cases through an implantable access portable. The proximal end 3312 may include knurling or other features that enable the user to grip the splitable cannula 3310.
The removable fixation 3320 may be used to hold the splitable cannula 3310 together, at least temporarily. For example, the removable fixation 3320 may hold the splitable cannula 3310 together while being inserted into an implantable access portal. In some examples, the removable fixation 3320 may be a weak adhesive, through other implementations are contemplated.
The removable obturator 3330 may fit snugly within the splitable cannula 3310 and provide a liquid-tight seal. The removable obturator 3330 may assist in placement of the splitable cannula system 3300. For example, a distal end of the removable obturator 3330 may include a conical or pointed end to help guide the splitable cannula system 3300 into position or into an implantable access portal.
The splitable cannula system 3400 may be used with a conventional implantable access port. Conventional access ports may be compliant, double-flanged devices that may be used to access arthroscopic workspaces. Use of the splitable cannula system 3400 is described below with respect to
Any of the apparatuses, including access ports and cannulas described herein, may be adapted to help fold or collapse the graft as it is inserted into the lumen of the access port, cannula, etc. For example, in some cases the apparatus may include a funnel-shape into which the implant delivery system is inserted once the graft is held within the jaws at the distal end of the implant delivery system. The funnel may curve or bend the graft as it is inserted into lumen, to prevent over ending (and cracking or breaking) the graft. In some cases the graft may be curved or bent sufficiently so that it may be driven through the narrower-diameter lumen of the cannula or port.
The method 3600 begins in block 3602 as an implantable access port is inserted into the patient. The implantable access port can be any feasible port including, but not limited to, the implantable access port 3501 of
Next, in block 3606 the removable obturator 3330 is removed from the splitable cannula 3310. In block 3608 the implant material and, in some cases, a portion of the implant delivery system are inserted through the splitable cannula 3310 and the implantable access portal 3501. For example, implant material may be attached to the implant delivery system. The user may insert both the implant material and a shaft of the implant delivery system into the splitable cannula 3310. This action may place the implant material in or near an implant region.
Next, in block 3610 the splitable cannula 3310 is removed from the implantable access port 3501. For example, while the implant material and the implant delivery system remain within the implantable access port 3501, the splitable cannula 3310 may be moved proximally allowing the splitable cannula 3310 to be separated and removed. Next in block 3612 the implant material may be affixed or attached to the patient. For example, the implant material may be moved forward through the implantable access port into the implant region. The user may then suture or otherwise attach the implant material to the patient.
It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.
The process parameters and sequence of steps described and/or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and/or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and/or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of” or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately.” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This patent application claims priority to U.S. provisional patent application No. 63/170,904, titled “TOOLS AND METHODS FOR GRAFT DEPLOYMENT,” filed on Apr. 5, 2021 and U.S. provisional patent application No. 63/315,080, titled “TOOLS AND METHODS FOR GRAFT DEPLOYMENT,” and filed on Feb. 28, 2022, each of which is herein incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/023469 | 4/5/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63170904 | Apr 2021 | US | |
| 63315080 | Feb 2022 | US |
