US20190269428A1 - Tissue engagement devices, systems, and methods - Google Patents
Tissue engagement devices, systems, and methods Download PDFInfo
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- US20190269428A1 US20190269428A1 US16/149,371 US201816149371A US2019269428A1 US 20190269428 A1 US20190269428 A1 US 20190269428A1 US 201816149371 A US201816149371 A US 201816149371A US 2019269428 A1 US2019269428 A1 US 2019269428A1
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- arms
- tissue
- engagement device
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- tube
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3478—Endoscopic needles, e.g. for infusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B2017/320044—Blunt dissectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
- A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
- A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
- A61B2017/3488—Fixation to inner organ or inner body tissue
Abstract
Devices and related methods to engage tissue layers to access the space between the layers are provided. The access devices include engagement arms that can be deployed and retracted to easily engage the top tissue layer and allow it to be separated from the underlying layer. The engagement arms are coupled to an actuation rod that is in turn coupled to a switch or lever that allows a user to control the actuation from outside the patient. The engagement arms and coupling to the actuation rod are unique and compact to ensure the entire mechanism fits in a small diameter shaft.
Description
- This application is a continuation of U.S. patent application Ser. No. 15/002,349, titled TISSUE ENGAGEMENT DEVICES, SYSTEMS, AND METHODS, filed on Jan. 20, 2016, which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62/105,289, titled TISSUE ENGAGEMENT SYSTEM AND METHOD, filed on Jan. 20, 2015, U.S. Provisional Patent Application No. 62/221,011, titled TISSUE ENGAGEMENT SYSTEM AND METHOD, filed on Sep. 19, 2015, and U.S. Provisional Patent Application No. 62/242,257, titled TISSUE ENGAGEMENT SYSTEM AND METHOD, filed on Oct. 15, 2015, the entire contents of each of which are hereby incorporated by reference herein.
- The present disclosure relates generally to systems, devices and methods for separating one tissue layer from underlying tissue or material. More specifically, the present disclosure relates to devices and methods for accessing the space between a tissue layer and an underlying structure, such as the pericardial space.
- In the field of cardiac medicine, minimally invasive therapies for treating conditions at the heart's surface, or epicardium, have been developed or contemplated. Example treatments include epicardial ablation, left atrial appendage ligation, lead placement, and drug delivery. An important element of these procedures is safely gaining access to the pericardial space through the pericardium, which is a thin, protective, multi-layer membrane surrounding the heart. As described in the book Basic Human Anatomy—A Regional Study of Human Structure by O'Rahilly et al (reference
FIG. 23-1 ), the outermost layer is the fibrous pericardium and the inner surface facing the pericardial space is a serous membrane called the parietal layer or pericardium. Opposing the parietal pericardium is another serous membrane called the visceral layer, which forms the outer surface of the epicardium. The pericardial space between the visceral and parietal layers is a thin film of serous fluid that provides lubrication. Because of its close proximity to the epicardium, creating an access port through the very thin pericardium can be difficult without injuring the underlying epicardium, heart muscles (myocardium tissue) and other structures such as blood vessels and nerves. The movement of the beating heart, breathing motions, presence of fatty surface tissue on the external surface of the fibrous pericardium, and toughness of the pericardium are some of the additional factors that can increase access difficulty. - Non-minimally invasive ways are considered surgical methods and use a thorascope to create an opening in the pericardium called a pericardial window. Presently, the accepted minimally invasive method for accessing the pericardial space between the pericardium and epicardium for purposes other than draining effusions (pericardiocentesis) involves carefully inserting a needle with fluoroscopic guidance as described by Sosa E., Scanavacca M., D'Avila A., and Pilleggi F. in “A New Technique to Perform Epicardial Mapping in the Electrophysiology Laboratory” in J Cardiovasc Electrophysiol., Vol. 7, pp. 531-536, Jun. 1996. The procedure today is still performed with a commercially available Tuohy needle (typically 17G or 18G) that accommodates a standard 0.035″ guide wire. St. Jude Medical has a general Epicardial Kit that includes different devices to perform epicardial procedures and a 17G Tuohy needle for access. More recently, some epicardial access procedures are being performed with a 21G Micropuncture needle which, because of the much smaller diameter, is more benign to unintended heart puncture, but very difficult to use because it is less stiff and requires exchanging to a larger, more stable 0.035″ guide wire. Micropuncture needle kits are commercially available from a number of different manufacturers. Using either needle type requires a high degree of skill and practice, and can be very time-consuming, and therefore this procedure has not been widely adopted, limiting the use of emerging epicardial therapies. Some known procedures utilize needles enhanced with electrical measurement capability or ultrasound to better monitor the needle tip position during entry into the pericardial space.
- It has been recognized that passing a needle through the pericardium could be made safer and less difficult by creating greater separation between the pericardium and epicardium. This has been demonstrated by the procedure known as pericardiocentesis, a procedure for draining excess fluid from the pericardial space. In this situation, the excess fluid creates pressure that forces the pericardium outward allowing safer needle passage. Various known methods to create this separation use vacuum apparatus, adhesion, or mechanical means (such as jaws or protruding needles). Further, some known devices for engaging tissue using needle-like members that bend or rotate into tissue. Known devices for engaging tissue or for creating a greater separation between the pericardium and epicardium suffer from a variety of drawbacks, however, as will be apparent from the disclosure herein. These limitations can be ameliorated or eliminated by embodiments disclosed hereafter.
- Certain embodiments disclosed herein include a mechanical engagement device that is sized to fit within a small opening such as a hypodermic tube. In some implementations, the engagement device consists of one or more small pivotable (e.g., pivotally mounted) arms with penetrating tips that engage tissue and bypass one another as they superficially pierce into the tissue. When fully actuated, the arms are positioned in such a way as to securely hold the tissue like hooks, allowing subsequent tissue manipulation such as lifting, pushing, pulling, or twisting. Lifting, for example, can create separation between the tissue and underlying layer or body of tissue beneath it. The pivotable arms can be sized and actuated to pierce into only the top layer of the tissue while minimizing the likelihood of injury or a puncture to the underlying layer. In some instances, this mechanism can be advantageous over existing devices and techniques in its ability to selectively engage thin tissue. In other or further instances, the device may be more robust to varying conditions, such as, for example, tissue thickness, toughness, and the presence of interfering tissue, such as fat.
- Some embodiments advantageously facilitate passage of a needle to the arms and beyond, e.g., via a channel or conduit along a length of the device. The channel is located so that the needle can pierce the tissue layer in close proximity to the arms and in a way that makes advantageous use of the tissue traction from the tip of the engagement device. After the needle has passed through the tissue it may be used to perform additional procedural steps such as the introduction of a guide wire, injection of fluids such as imaging contrast agents or drugs, introduction of diagnostic or therapeutic devices, and the like.
- The written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:
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FIG. 1 is an anterior view of the thoracic cavity of a patient. -
FIG. 2 illustrates a lateral view of the thoracic cavity of the patient. -
FIG. 3 illustrates a view of the chest of the patient and includes illustration of a subxiphoid approach. -
FIG. 4 shows a top side perspective view of an embodiment of a tissue engagement device in an undeployed or retracted state. -
FIG. 5 shows a bottom side perspective view of the tissue engagement device in the undeployed state. -
FIG. 6 shows a cross sectional view of the tissue engagement device taken along the view line 6-6 inFIG. 4 , or stated otherwise, taken along a longitudinal axis of the device, that further depicts a puncture needle inserted through the device. -
FIG. 7 is an enlarged perspective view of a proximal portion of the tissue engagement device that shows a handle and a lever that is positioned in a deployed state. -
FIG. 8 shows an exploded perspective view of the portion of the tissue engagement device that is depicted inFIG. 7 . -
FIG. 9 shows a perspective view in partial cross-section of a tip of the tissue engagement device in the undeployed state. -
FIG. 10 shows a perspective view in partial cross-section of the tip of the tissue engagement device in the deployed state. -
FIG. 11 depicts the tip of the tissue engagement device, with portions thereof reduced to broken lines for clarity, at various sequential stages of deployment. -
FIG. 12 shows perspective views of the same sequential stages of deployment of the tip of the tissue engagement device as those shown inFIG. 11 . -
FIG. 13A-13F depict the tip of the tissue engagement device engaging a tissue layer, with the stages of deployment of each ofFIGS. 13A-13F corresponding with the six stages of deployment depicted in each ofFIGS. 11 and 12 . -
FIG. 14A depicts a side view of the tissue engagement device engaging a tissue layer at a shallow angle. -
FIG. 14B depicts a side view of the tissue engagement device pulling the tissue layer back. -
FIG. 14C depicts a side view of the tissue engagement device deploying a puncture needle through the tissue layer. -
FIG. 14D depicts a side view of the puncture needle being advanced into the pericardial space. -
FIG. 14E depicts a side view of an introduction of a guide wire into the pericardial space, and the guide wire can be used to introduce other devices into the pericardial space. -
FIGS. 15A-15D depict side views of the tip of the tissue engagement device at various stages of a method in which the device is used to tunnel through adipose tissue on the surface of the fibrous pericardium. -
FIGS. 16A is a detailed view of an embodiment of a single engagement arm. -
FIG. 16B is a perspective view of the engagement arm that illustrates a bevel to increase tip sharpness. -
FIG. 17 shows a detailed view of another embodiment of an engagement arm with a rounded tip to reduce tissue injury. -
FIG. 18 shows a detailed view of yet another embodiment of an engagement arm with teeth to enhance securement of a tissue layer. -
FIG. 19 is a detailed view of the tip of a tissue puncturing needle intended to pass through the tissue layer after securement of the tissue layer with the engagement arms of the tissue engagement device. -
FIG. 20 is a perspective view of a proximal hub for a tissue puncturing needle showing a thread feature for controlled needle advancement; the illustrated hub also has a luer fitting for attachment to a syringe. -
FIG. 21 is an exploded perspective view of an embodiment of a device handle that incorporates a dial that engages the thread feature depicted inFIG. 20 . -
FIG. 22A is a detailed perspective view of a tip of another embodiment of a tissue engagement device in which a needle pathway is between the engagement arms, which are depicted in a retracted state. -
FIG. 22B is a detailed perspective view of the tip ofFIG. 22A that depicts the engagement arms in a deployed state. -
FIG. 23A is a detailed perspective view of the tip of yet another embodiment of a tissue engagement device in which a needle pathway is on the top of the engagement arms, which are depicted in a retracted state. -
FIG. 23B is a detailed perspective view of the tip ofFIG. 23A that depicts the engagement arms in a deployed state. -
FIG. 24A is a detailed perspective view of the tip of a further embodiment of a tissue engagement device having engagement arms that are depicted in a retracted state. -
FIG. 24B is a detailed perspective view of the tip ofFIG. 23A that depicts the engagement arms in a deployed state. -
FIG. 25A depicts detailed sequential views of the tip of another embodiment of a tissue engagement device in which an actuation rod is pushed relative to a shaft to deploy the engagement arms, which are pivotally mounted to the actuation rod. -
FIG. 25B depicts detailed sequential views of the tip of yet another embodiment of a tissue engagement device in which an actuation rod is pulled relative to a shaft to deploy the engagement arms, which are pivotally mounted to the actuation rod. -
FIG. 25C depicts detailed sequential views of the tip of a still further embodiment of a tissue engagement device in which an actuation rod is pulled relative to a shaft to deploy the engagement arms, which are pivotally mounted to the shaft. -
FIG. 26 depicts a method of using the engagement arms of a tissue engagement device to engage and manipulate tissue. -
FIG. 27A is a perspective view of an embodiment of a handle for a tissue engagement device that includes an adjustable needle brake. -
FIG. 27B is a cross-sectional view of the handle taken along theview line 27B-27B inFIG. 27A . -
FIG. 28A is a perspective view of another embodiment of a tissue engagement device that incorporates a threaded needle advancement mechanism and a fitting for a locking luer connection. -
FIG. 28B is an obverse perspective view of the tissue engagement device ofFIG. 28A . -
FIG. 29 is a detailed perspective view of a handle portion of the tissue engagement device ofFIG. 28A . -
FIG. 30 is an exploded perspective view of the portion of the tissue engagement device depicted inFIG. 29 . -
FIG. 31 is a cross-sectional view of the tissue engagement device taken along the view line 31-31 inFIG. 29 . -
FIG. 32 is a view of a detachable needle assembly that attaches to the tissue engagement device ofFIG. 28 . -
FIG. 33 is a detailed, exploded view of a proximal end of the detachable needle. -
FIG. 34 depicts an embodiment of an engagement arm that is compatible with tissue engagement devices, the engagement arm featuring a shield protrusion capable of preventing inadvertent tissue injury when pulling the engagement arm while it is actuated and/or limiting the penetration depth of the arm into tissue. -
FIGS. 35A-35F depict various stages of deployment of another embodiment of a tissue engagement device that includes alternate engagement arms with shield protrusions. -
FIG. 36 depicts an illustrative rapid retraction mechanism adapted to a threaded coupling between a needle assembly and a device handle. -
FIG. 37 depicts an embodiment of a device having a lockable collar that fits over a tube shaft. - Illustrative embodiments are described in the following with reference to the drawings. It should be understood that such embodiments are by way of example only and are merely illustrative of the many possible embodiments which can represent applications of the principles of the present disclosure. Various changes and modifications obvious to one skilled in the art to which the present disclosure pertains are deemed to be within the spirit, scope and contemplation of the present disclosure as further defined in the appended claims. The illustrative embodiments described herein are not intended to be exhaustive or to limit the disclosure to the precise forms disclosed in the following detailed description. Rather, the illustrative embodiments described herein are chosen and described so those skilled in the art can appreciate and understand the disclosed principles and practices.
- The inventors have recognized that known devices and methods for accessing the pericardial space, such as those discussed in the Background above, have been unsuccessful and impractical in clinical use. For example, capital equipment and facility connections, such as for vacuum, are undesirable, increase cost, require maintenance, and take up space in generally crowded clinical labs. The required penetration angle can vary widely and be very shallow too (e.g. almost 0 degrees to almost 90 degrees, with shallow being around 30 degrees or less), and varying approaches to target anterior and inferior areas of the heart also make it difficult to engage the pericardium. Further, varying fat and loose connective tissue adjacent the pericardium interferes with engagement. Additionally, known devices are not designed specifically for engaging a tissue layer (versus a thicker mass of tissue like in lead anchoring devices) and do not have features for creating an access pathway for a guidewire or catheter type device into the potential space between the tissue layer being engaged and an underlying tissue layer. Embodiments disclosed herein address, ameliorate, or eliminate one or more of the foregoing limitations and/or other limitations of prior art devices. Certain devices and methods, for example, can reliably and safely separate the pericardium from the epicardium and facilitate passage of a needle or guidewire into the pericardial space.
- Referring to
FIG. 1 , an anterior view of the thoracic cavity, the pertinent anatomical structures such as thediaphragm 33, leftlung 21,right lung 22,aorta 23, andheart 10 are shown. Aportion 20 of theparietal pericardium 11 is cut away to so that theunderlying epicardium 12 andepicardial fat 13 can be seen. - Referring to
FIG. 2 , a midsection lateral view of the thoracic cavity is shown again showing the heart thepericardium 11 and further showing theepicardium 12, thepericardial space 14, and theliver 15. For additional reference thesternum 25 andspine 26 are shown. Thepericardial space 14 exists between thepericardium 11 and theepicardium 12. Under normal conditions, the surfaces of the epicardium and pericardium enclose a potential space; thus there is minimal to no clearance between the two layers, as described by Swale M. et al, “Epicardial Access: Patient Selection, Anatomy, and a Stepwise Approach.” The Journal 240 (2011). In this figure, ananterior approach 31 is depicted, which is a preferred pericardial access approach and one used most commonly today. This approach is called the anterior approach because it provides access into the pericardial space on the anterior side of the heart. In this figure, inferior approaches 32 and 34 are also shown, and provide access to the inferior side of thepericardial space 14. Theinferior approach 32 requires passing through thediaphragm 33 and for this reason is also referred to as a transdiaphragmatic or subdiaphragmatic approach. Both the anterior approach and 31 and theinferior approach 34 are called subxiphoid approaches and differ in the angle to the heart. -
FIG. 3 shows a view of the chest of a person with thexiphoid process 50 and the 1st costal 51 to the 10th costal 60 identified and numbered sequentially (i.e., the 2nd costal 52, 3rd costal 53, etc. through the 10th costal 60). Anintercostal approach 61 shown here between the 6th and7th ribs subxiphoid approach 62 is shown and its position relative to the xiphoid 50 and thecostal margin 63. With the heart always positioned more to a person's left side thesubxphoid approach 62 is angled towards the person'sleft shoulder area 64. -
FIGS. 4 through 6 illustrate an embodiment of atissue engagement device 71 which, referring toFIG. 4 , has ahandle 72, atube 73 and atip 74. Thehandle 72 has amain body 81 in which sits anactuation lever 75. In the illustrated embodiment, theactuation lever 75 extends from atop side 105 of thehandle 72 and, more generally, thedevice 71.Lever 75 is shown in the forward position, which is whenlever 75 is towardssurface 76 ofhandle 72 and theengagement arms 96 and 97 (seeFIG. 9 ) are retracted. Abottom side 106 ofhandle 72 anddevice 71 is shown inFIG. 5 . Thelever 75 can be switched to the rear position, which is when it is towardssurface 77, as is also later shown inFIG. 7 . Apuncture needle 79, which has atip 135, as shown inFIG. 6 , enters through theproximal end 80 of thehandle 72 and emerges through aslot 78. Theslot 78 is part of aneedle pathway 91.FIG. 4 also shows that in the illustrated embodiment, thetube 73 fits into ahandle body 81. Thepuncture needle 79 is shown straight but can be alternatively curved along any portion, which can help bring thetip 135 closer to thetip 74 as theneedle 79 is deployed. -
FIG. 7 is a detail view of thehandle 72, showing wheretube 73 enters thebody 81. In this figure,lever 75 is switched to the rear position, which is whenengagement arms 96 and 97 (seeFIG. 9 ) are deployed. -
FIG. 8 is a perspective exploded view of thehandle 72, which showslever 75 andbody 81.Covers hubs lever 75. In this embodiment, thecovers screws body 81, and thread intocovers hubs covers body 81 of the handle and are permitted to rotate therein. In this way, thelever 75 can pivot relative to themain body 81.Tube 73 fits intoholes body 81 and is rigidly attached tobody 81. In the illustrated embodiment,tube 73 defines a slot 89 at a proximal end thereof, which allows the puncture needle (seeFIG. 6 ) to pass through.FIG. 8 also depicts anactuation rod 90 that defines a groove orneedle pathway 91 and through which apin 92 is pressed transversely. In the illustrated embodiment,actuation rod 90 fits inside oftube 73 and slides freely within. Stated otherwise, thetube 73 defines alumen 99 that is sized to receive theactuation rod 90 therein. Stated otherwise, in some embodiments, thelumen 99 can define a maximum interior width that is larger than a maximum exterior width of theactuation rod 90. In the illustrated embodiment, thelumen 99 is sufficiently large to permit theactuation rod 90 to translate freely or within thetube 73.Lever 75 hasgrooves hubs pin 92 therein. In the illustrated embodiment, thepin 92 position is not on the same axis as thehubs lever 75 is pivoted it can move and control the position ofactuation rod 90. Stated otherwise, in the illustrated embodiment, thepin 92 position is not restricted to a rotational axis of thehubs hubs lever 75, and thus of thehubs pin 92, which can translate theactuation rod 90 in a distal direction or a proximal direction, respectively. In order to accommodate thepin 92 motion, thetube 73 has acutout 94. -
FIGS. 9 and 10 are close-up cutaway views of thetip 74 of thedevice 71 showingengagement arms tube 73 hasslot 100 and is shown with theactuation rod 90 in place.Actuation rod 90 hastip 104,slot 101 andposts arms Guide 110 is shown withpost 111 that fits into ahole 112 intube 73 to hold it in place. In the embodiment shown, thetip 113 ofguide 110 has a chamferedface 114 which aligns with thechamfered end 115 oftube 73. This chamferedface 114 is on the same side as thebottom side 106 identified inFIGS. 5 and 6 . Stated otherwise, in the illustrated embodiment, the chamferedface 114 is at a bottom side of thedevice 71.Guide 110 also hasguide post 116 extending from it.Arms slots 117 and 118 (see alsoFIG. 16A ) into which post 116 slides.Slots 100, which are positioned at opposite sides of thetube 73 in the illustrated embodiment, allowengagement arms tube 73 during deployment.Chamfered face 114 andchamfered end 115 allowarms tip 74 and the surface of the tissue layer to be engaged is shallow, as compared, for example, with an arrangement in which a transverse cross-sectional profile of thetube 73 and/or theguide 110 is not reduced or is unaltered along the distal end of thedevice 71. The chamferedface 114 andchamfered end 115 may be said to define an acute angle relative to the longitudinal axis AL of the device 73 (which is also a longitudinal axis of thetube 73, in the illustrated embodiment). This angled configuration can permit the chamfered faces 114, 115 to rest against a tissue layer (e.g., thelayer 130 described below) while thetube 73 is at an acute angle relative to the tissue layer. - Now referring to
FIG. 4 , andFIGS. 6 through 10 , as thelever 75 moves from its forward position shown inFIG. 4 to its rear position shown inFIGS. 6 and 7 , theactuation rod 90 moves backwards from its position shown inFIG. 9 to its position shown inFIG. 10 . Stated otherwise, as can be seen by comparingFIGS. 9 and 10 , theactuation rod 90 is retracted into thetube 73. InFIG. 9 , thetip 104 of theactuation rod 90 extends past adistal face 120 of thetube 73. InFIG. 10 , a greater portion of thetip 104 has been drawn into an interior of thetube 73 and adistal face 121 of thetip 104 extends only slightly past the distal end of thetube 73 in an axial direction. In some embodiments, thetip 104 may be drawn fully into an interior of thetube 73 such that thedistal face 121 of thetip 104 is either flush with or axially recessed relative to thedistal face 120 of thetube 73. Thelever 75 controls theactuation rod 90 motion because of how the two are connected together via thepin 92 andgrooves pin 92 follows, as discussed previously. The backward movement ofactuation rod 90 causes thearms posts slots arms guide post 116. In particular, theslots guide post 116 to cam the arms to the outstretched, deployed, or expanded configuration, as discussed further below. When theactuation rod 90 is fully retracted, thenarms FIG. 10 . -
FIGS. 11 and 12 further illustrate the deployment motion oftip 74, specifically showingtip 74 in different states or stages asactuation rod 90 is moved backward relative to thetube 73 to movearms FIG. 11 shows side views of the distal portion of thedevice 71 in the different states, andFIG. 12 shows perspective views of the distal portion of thedevice 71 these same states. Each figure includes a legend identifying a forward (or distal) direction and a backward (or proximal) direction. In the retracted state, which corresponds with the leftmost orientation inFIGS. 11 and 12 , thetip 104 is positioned in alignment with the penetratingtips arms tips arms distal face 121 of thetip 104 ofactuation rod 90 in the axial direction. Moreover, in the illustrated embodiment, the outer edges of thearms tip 104. When thearms arms tip 104. - With continued reference to
FIGS. 11 and 12 , the outer profile defined by the movingarms tip 104 during deployment of thearms arms distal face 121 of thetip 104 in the axial direction throughout deployment as theactuation rod 90 is retracted. Indeed, in the illustrated embodiment, at least a portion of eacharm distal face 121 of thetip 104 in each of the five stages or orientations depicted at the right side ofFIG. 12 . - A distance between the
distal face 121 oftip 104 and the penetratingtips arms arms tips distal face 121 of thetip 104. Changing this relative distance can influence the depth to which thearms tips distal face 121 by a distance of between 0 inches and 0.030 inches when the arms are in the retracted state (e.g., the leftmost configuration inFIG. 11 ). It is contemplated that penetratingtips arms tips tube 73. - Referring now to
FIGS. 11 and 13A-13F , in some embodiments, thetips arms arms tip 104 is pressed against soft tissue, a bulge of tissue forms inspace 139. The gap or space d can be sized such that a layer ofthin tissue 130 will preferentially bulge intospace 139 but underlying tissue 131 (i.e., a tissue layer that is beneath the tissue layer being engaged) will not. A transverse width of the space d may be customized for a specific application; for example, when used to engage perineal membrane with a thickness of 0.020 to 0.040 inches (0.5 to 1.0 mm), a width d is preferably twice the membrane thickness, or approximately 0.040 to 0.060 inches (1.0 to 2.0 mm). It is further contemplated that in some embodiments, the starting width of the space d may advantageously be zero or substantially zero; i.e., there is no gap between thetips arms tips device 71. In other embodiments, the space d is less than 0 inches when thearms tips - Stated in yet another manner, in the illustrated embodiment, the
tips FIGS. 11 and 12 and inFIG. 13A . In this state, thetips device 71 and are directed inwardly (e.g., transversely inwardly or radially inwardly), and in the illustrated embodiment, are directed toward the longitudinal axis AL. Stated otherwise, thetips FIG. 11 , the imaginary longitudinal plane is perpendicular to the plane of the page and extends through the longitudinal axis AL. As thearms tips arm 96 rotates in a clockwise direction to move thetip 132 substantially leftward and upward (e.g., proximally), and thearm 97 rotates in a counterclockwise direction to move thetip 133 substantially rightward and upward (e.g., proximally). In this manner, thearms tips FIGS. 11 and 12 (counting from left to right), and inFIGS. 13B-13F , thetips FIGS. 11 and 12 (counting from left to right) and as of the orientation ofFIG. 13B , thetips tips device 71. In the illustrated embodiment, thetips tips - With reference to
FIG. 11 , in the retracted or undeployed state, thearms tube 73. It is noted that the terms “diameter” and “tube” do not necessarily imply a cylindrical configuration of thetube 73. Although the illustrated embodiment of thetube 73 is substantially cylindrical, other suitable shapes and configurations of thetube 73 are contemplated. In the illustrated embodiment, when thedevice 71 is in the undeployed state, the size of the gap d is less than the maximum lateral width W of thearms tube 73. Thearms tube 73 when in the undeployed state. - As can be appreciated from the rightmost orientation in
FIGS. 11 and 12 and fromFIG. 13F , when thearms arms tube 73. Stated otherwise, the distance between thetips tube 73 when thearms - With reference again to
FIG. 11 , in the illustrated embodiment, thetips tube 73. Stated otherwise, in the illustrated embodiment, throughout deployment of thearms tips arms tube 73. The rightmost depiction inFIG. 11 includes apath 125 that is traveled by thetip 133 during deployment of thearms illustrated path 125 is arc shaped and may, in some instances, be substantially semicircular (other arc shapes may also be defined in further embodiments). Moreover, in tracing the arc-shapedpath 125, no component of movement of thetip 133 is directed distally. Rather, the movement only includes rightward (transverse) and upward (proximal) components in the depicted orientation. Moreover, during the early stages of deployment, the movement is primarily transverse, whereas in later stages, the movement increasingly includes proximal components. Thetip 132 traces a path having the same arc shape, but does so in the opposite transverse direction. However, thetips tips - As can be appreciated from the foregoing discussion, and with additional reference to
FIGS. 13A-13F , the paths traced by thetips thin tissue 130. For example, as previously mentioned, thegap 139 between thetips thin tissue 130 therein when the distal end of thedevice 71 is pressed against the tissue layers 130, 131. As thetips underlying tissue layer 131. Accordingly, thetips thin tissue 130 without engaging theunderlying tissue layer 131. As thetips thin tissue 130 is further engaged by thearms underlying tissue layer 131. - With reference again to the rightmost depiction in
FIG. 11 , and with additional reference toFIG. 16A , thearms curved edges tips FIGS. 13A-13F , as thetips arms curved edges underlying tissue layer 131 without engaging this tissue. Stated otherwise, thecurved edges tissue layer 131 tissue positioned beneath thelayer 130 as thecurved edges tissue layer 131. In some embodiments, thecurved edges tissue engagement device 71 throughout an entirety of a transition from the retracted orientation to the actuated orientation to inhibit trauma to the additional tissue. - With reference again to
FIGS. 11 and 12 , mechanics of the deployment of thearms actuation rod 90 moves backward it moves the proximal portions of thearms guide 110 and thepost 116. Thegrooves arms post 116, and causearms posts grooves post 116 causes thearms tip 104 relative to penetratingarm tips 132 and 133 (e.g., the amount of axial distance between thedistal face 121 and thetips 132, 133) can be modified by changing the interaction between the pivots and groove 117 and 118 geometry. It is contemplated that design variations can include configurations in which thetip 104 moves axially faster or slower than the axial displacement of penetratingtips tip 104 could remain fixed relative to the movement of penetratingtips -
FIGS. 13A-13F show specifically how the same deployment motion and method described inFIGS. 11 and 12 is used to engage atissue layer 130 that sits directly on top ofunderlying tissue 131. The deployment method and engagement with tissue is a continuous motion but for clarity is shown in discrete stages in each ofFIGS. 13A-13F . -
FIG. 13A demonstrates that thetip 74 of device 71 (witharms tissue 130 with enough force that bothtissue layer 130 andunderlying tissue 131 are slightly depressed. This results in slight bulging of tissue betweenarms tips only tissue layer 130 fully bulges intospace 139 between penetratingtips tips FIG. 13B , thetips tissue 130 while displacingunderlying tissue 131 away. In some instances, therounded edges underlying tissue 131 without engaging it. Continuing this motion, as penetratingtips tissue 130 without puncturingunderlying tissue 131. - With reference to
FIGS. 13B-13E , lever 75 (seeFIGS. 4-7 ) is transitioned from its forward position towards its rear position causingactuation rod 90 to move backward relative to thetube 73 and causingarms arms tips tissue layer 130 and gradually lift it away fromunderlying tissue 131. For example, thetips tissue layer 130. In other instances, thetips layer 130. Rather, thetips tissue layer 130 without passing through it. In either case, as thearms arms tissue layer 130 in opposite directions. -
FIG. 13F depicts thearms tips tissue layer 130. Theentire device 71 can be maneuvered or pulled back to further manipulatetissue layer 130 fromunderlying layer 131, and increase thespace 134 between the twolayers space 134 is the pericardial space of a patient's heart. -
FIGS. 14A-14E depict stages of a method in which thearms FIG. 6 ) when engaging tissue layer at a shallow contact angle relative totissue layer 130. One or more of the stages of this method can be combined with the method for engaging a tissue layer depicted inFIGS. 13A-13F . With reference toFIG. 14A , thedevice 71 is pressed against and depressestissue layer 130 andunderlying tissue 131. This is a similar method stage to that shown inFIG. 13A . As shown, for example, inFIGS. 9 and 10 , thedistal face 121 of thetip 104 ofactuation rod 90 is relatively blunt making it very safe to press hard against tissue without risk of puncturing through the tissue. For example, thetip 104 is sufficiently blunt to be pressed against the tissue layers 130 or 131 without penetrating them. This is also true where thetip 104 contacts these layers at contact angles greater than the contact angle depicted inFIG. 14A . In the illustrated embodiment, thepuncture needle 79 is loaded intodevice 71 and is positioned so that thetip 135 passes throughactuation rod 90 and emerges fromtube 73 through opening 78 (seen inFIGS. 5 and 6 ). -
FIG. 14B shows how theengagement arms tissue layer 130 and lift it away fromunderlying tissue 131. This stage is similar to that depicted inFIG. 13E . - With reference to
FIG. 14C , thepuncture needle 79 can be advanced forward (distally) until thetip 135 punctures throughtissue layer 130. Prior to advancing thetip 135 in this manner, thetissue layer 130 may be further lifted from theunderlying layer 131 be pulling back on thedevice 71 to expand thespace 134. Such expansion of thespace 134 is also depicted inFIG. 14C , as can be appreciated by comparing this figure withFIG. 14B . - With reference to
FIG. 14D , thepuncture needle 79 continues to be advanced forward until theentire tip 135 is inside thespace 134 betweentissue layer 130 andunderlying tissue 131.FIG. 14E shows how a standard guidewire 136 (in some embodiments, the guidewire can have a diameter of from about 0.014 inches to 0.035 inches) can be passed down a lumen of thepuncture needle 79 and into thepotential space 134 created by (e.g., defined between) thetissue layer 130 andunderlying tissue 131. - In many applications, the portion of the
device 71 shown inFIGS. 14A-14E will be in tissue and not directly seen by a user. At any suitable point during the method (e.g., at or between any steps shown inFIGS. 14A-14D ) it is possible to inject contrast media, or other agents or materials, so that the area outside thetip 135 ofneedle 79 can be seen with fluoroscopy or any other suitable imaging technique to aid visualization. -
FIGS. 15A-15D show how thedevice 71 and certain features thereof can be used to overcome, for example, the challenge in gaining access through the pericardium due to fat and loose connective tissue. In these figures, the fat and loose connective tissue is identified withreference numeral 140 on the surface of the pericardium, which would be equivalent totissue layer 130.Tissue 140 has different mechanical properties thantissue layer 130 andunderlying tissue 131 and can be more easily pushed apart with a blunt dissection method. - With reference to
FIG. 15A , a method can include pushing thetip 74 ofdevice 71 against thesurface tissue 140. As shown inFIG. 15B , the lever 75 (seeFIGS. 4-7 ) is actuated to causearms FIG. 15B . - With reference to
FIG. 15C , while forward pressure is applied to thedevice 71, thelever 75 is cycled forward and backward, causingarms bidirectional arrows tissue layer 140. Any suitable number of actuation cycles is possible to achieve the desired penetration. -
FIG. 15D depicts how the cycling method just described can allow thetip 74 to tunnel or dissect through thetissue layer 140 and bring it much closer to thetarget tissue layer 130. Additional cycling, while advancing the device forward, may be employed to bring thetip 74 into contact with the tissue layer 130 (but this additional tunneling to thelayer 130 is not explicitly shown here). -
FIG. 16A shows a top plan view of an embodiment ofarms device 71. In the illustrated embodiment, thearms device 71. As they are flat, thearms arms arms arms holes grooves centerlines holes grooves tips axis tips inside edges FIG. 13F , thetissue layer 130 may rest on theshelves arms shelves tissue layer 130. Theshelves tissue layer 130 away from thetissue layer 131. - With reference to
FIG. 16B , in some instances, it may be desirable to increase the sharpness neartips bevel planes 175 that are at angles relative to the main planar orientation of thearms - Many different embodiments of the arms are contemplated.
FIG. 17 depicts another embodiment ofarms arms arms holes grooves Centerlines grooves arms arms tips axes axis centerlines FIG. 16A . Thetips inside edges arms arms gap 139 inFIG. 11 . -
FIG. 18 depicts another embodiment ofarms arms arms holes grooves Centerlines grooves arms arms tips axis axis centerlines FIG. 16A . In the illustrated embodiment, the angles are the same as those for thearms FIG. 17 . Thetips arms inside edges tissue layer 130. -
FIG. 19 shows a perspective view of a distal end of thepuncture needle 79. Theneedle 79 includes atube 200 withaxis 203. Thetube 200 is preferably round but can be any shape.Tip 135 has anopening 201 anddistal edge 202. Theopening 201 faces away from themain axis 203 and prevents coring of tissue that can enter thedistal opening 201 as theneedle 79 is pushed along itsaxis 203 through tissue. Stated otherwise, theneedle 79 can be a non-coring needle. Other embodiments can be generally any shape (e.g., any suitable cross-sectional configuration) and can provide any suitable orientation foropening 201. Thetube 200 can define alumen 205 that is used as a delivery pathway for accessory delivery, such as a guidewire and/or contrast media during the access approach, as previously discussed. -
FIGS. 20 and 21 depict another embodiment of aneedle 300 and an embodiment of amating handle 400, which enables improved motion control of the needle 300 (relative to motion control of the needle 79), and improved means to deliver contrast media and guidewire accessories. Theneedle 300 includes atube 301 and atip 302 withopening 303. A fitting 304 is attached to the proximal end ofneedle 300. The fitting 304 includes adistal hub 305, athread 306, and aproximal hub 307. ALuer type connection 320 is integrated into the proximal end of the fitting 304 withears needle 300 interfaces with thehandle 400. - As shown in
FIG. 21 , thehandle 400 includes abody 401 and aknob 402 that is threaded onto theneedle thread 306. Thehandle 400 also haslever 404 with hubs 406 (such as thehubs FIG. 8 ).Covers screws handle body 401, and are positioned over thelever hubs 406 so thatlever 404 can pivot. Cover 411 is fastened to handlebody 401 usingscrews distal hub 305 so that fitting 304 is guided throughhandle body 401. Thehandle body 401 has matching internal grooves (not visible) forguides knob 402 is rotated. - In use, the
knob 402 can be rotated in either direction, which advances or retractsneedle 300 without letting theneedle 300 rotate. Stated otherwise, rotation of theknob 402 can result in distal or proximal translation of theneedle 300. TheLuer connection 320 is the common standard type used to interconnect fluid fittings and syringes together. Any other suitable connection interface is contemplated. - The
Luer connection 320 can enable additional other functions. One example is that a syringe with contrast media can be connected to the Luer fitting 320, so that as thedevice 71 is being advanced towards the heart, contrast can be injected to verify the position continuously during the approach. A second example is that once thepuncture needle 300 has been placed into the pericardial space, a means for delivering a guide wire into the pericardial space is established. Once a guidewire is delivered, thedevice 71 can be removed leaving the guidewire in place, which then provides the means to deliver other medical devices such as sheaths and in turn then mapping and ablation catheters. -
FIGS. 22A and 22B depict another embodiment of atissue engagement device 510. Thedevice 510 is shown in an undeployed state inFIG. 22A and is shown in a deployed state inFIG. 22B . Thedevice 510 defines aneedle pathway 500 that is either parallel to or collinear with a central axis of an outer ormain tube 501. The needle pathway is between (e.g., extends between)tissue engagement arms needle pathway 500 is integral to (or defined by) theactuation rod 504. Thedevice 510 includes apin 505 that is attached to theactuation rod 504. Thearms pin 505 at opposite sides of theneedle pathway 500. In this respect, thearms device 71 described above.Engagement arms grooves Pins main tube 501. Stated otherwise, thepins main tube 501. Asactuation rod 504 is pushed forward (e.g. distally) it movesengagement arms pin 505 as theirgrooves pins device 71, where two pivot points were used and a single post effected camming of the arms. Here, a single pivot axis is used (i.e., the axis passing through the post 505), and twoseparate pins 508 are used to individually effect rotation of eacharm actuation rod 504 moves forward (distally) rather than backwards (proximally) to deploy theengagement arms needle path 500 is also parallel to the sidewall of the shaft ortube 501 and is fully encompassed thereby, whereas theneedle path 91 of thedevice 71 is angled relative to itstube 73 and passes through the sidewall thereof, as seen inFIG. 6 . -
FIGS. 23A and 23B show another embodiment of atissue engagement device 520 that defines astraight needle path 526 that is parallel to themain tube 521. Unlike with thedevice 510, however, theneedle path 526 does not pass between theengagement arms needle path 526 is above theengagement arms needle path 526 is laterally offset from theengagement arms device 520 includes anactuation rod 522 to whichengagement arms actuation rod 522 is used to deploy and retractengagement arms device 520 includes astationary tip 523 that defines aneedle opening 529. Thetip 523 guards both the top and bottom sides of theengagement arms Stationary tip 523 is fixedly attached to the distal end ofmain tube 521. -
FIGS. 24A and 24B depict yet another embodiment of atissue engagement device 540 in undeployed and deployed states, respectively. Thedevice 540 defines astraight needle path 550 that is parallel to amain tube 541 and is positioned aboveengagement arms engagement arms actuation rod 542. Theneedle path 550 is defined by theactuation rod 542 and is bordered along an upper end thereof by thetube 541. -
FIGS. 25A-25C are detailed images of distal tips of further embodiments oftissue engagement devices FIGS. 25A, 25B depict the differences between a pull versus a push actuation motion where engagement arms are pivotally mounted to an actuation rod. InFIG. 25C , the engagement arms are pivotally mounted to the tube. - In
FIG. 25A , thedevice 580 includes atube 560, anactuation rod 562, andengagement arms tube 560 has adistal edge 561 andactuation rod 562 has adistal edge 563. Asactuation rod 562 is pulled and moves proximally relative to thetube 560, theengagement arms - In
FIG. 25B , thedevice 581 includes a shaft ortube 570 that hasdistal edge 571. Anactuation rod 572 hasdistal edge 573.Engagement arms actuation rod 572. Asactuation rod 572 moves distally (e.g., is pushed) relative to thetube 570, theengagement arms -
FIG. 25C depicts another embodiment of atissue engagement device 600 that includes a sheath, shaft, ortube 610 and an actuation member oractuation rod 620. Thedevice 600 further includesengagement arms engagement arms camming grooves engagement devices engagement arms tube 610, rather than being pivotally attached to theactuation rod 620. In particular, bothengagement arms pivot post 640, which post is fixedly secured to thetube 610. Twocamming posts 641 642 are fixedly secured to theactuation rod 620. Thedevice 600 is transitioned from the retracted state to the deployed state by moving theactuation rod 620 proximally relative to thetube 610. Conversely, thedevice 600 is transitioned from the deployed state to the retracted state by moving theactuation rod 620 distally relative to thetube 610. As with theactuation rod 90 depicted inFIGS. 9 and 10 , which defines aslot 101, theactuation rod 620 can define aslot 650. Theslot 650 can be sized to permit passage of thepivot post 640. - Any other suitable arrangement is contemplated for actuating the engagement arms. For example, in some embodiments, one or more engagement arms can be pivotally mounted to an actuation rod, one or more additional engagement arms can be pivotally mounted to the tube, and relative movement between the actuation rod and the tube (to which one or more camming posts may be mounted) can transition the actuation arms between the retracted and deployed states.
-
FIG. 26 depicts amethod 800 for engaging tissue. Themethod 800 has been described previously herein, and it should be understood that any suitable combination of steps of the method are contemplated. For example, themethod 800 includes nine stages orsteps method 820 can include thesteps method 820 may be considered a core method that may be common to numerous methods that employ various permutations of thesteps 801 through 809. - At
step 801, the distal end of a tissue engagement device (e.g., a surgical grasping instrument), such as any of the devices disclosed herein, is introduced inside the body of a patient. Any suitable method for introducing the tissue engagement device is contemplated, including those known in the art for introducing trocars or other small diameter instruments into a patient. - At
step 802, the distal end of the instrument is guided toward a region of soft tissue. Any suitable guiding techniques are contemplated, including fluoroscopy methods such as previously mentioned. - At
step 803, the distal end of the tissue engagement or grasping instrument is pushed against the region of soft tissue. As previously discussed, in various embodiments, the grasping instrument can include a plurality of engagement (e.g., penetrating) tips that can, in some instances, define a gap into which a thin layer of tissue is received. - At
step 804, two or more piercing elements are deployed. The piercing elements can include tips that approach and then bypass one another. The tips may then move to radially extended positions as they pass into the tissue. Step 804 can correspond, for example, to the steps disclosed inFIGS. 13A-13F . - At
step 805, the two or more piercing elements are retracted and they redeployed.Step 805, repeated iteratively, can correspond with the method described with respect toFIGS. 15A-15D . - At
step 806, the tissue is manipulated while the piercing elements are maintained in the deployed position so as to maintain a grasp on the soft tissue layer. For example, the tissue engaging or grasping device can be pulled in a proximal direction to provide additional space between adjacent tissue layers (e.g., to enlarge the pericardial space). This step can correspond with the stage depicted, for example, inFIGS. 14B and 14C . - At
step 807, additional procedures are performed, such as passing a delivery needle through the soft tissue and passing a guidewire through the needle. This step can correspond with the stages depicted, for example, inFIGS. 14C-14E . - At
step 808, the soft tissue is released as the piercing elements are retracted to their original position. Stated otherwise, returning the piercing elements to the undeployed state effects a release of the soft tissue. - At
step 809, the surgical grasping device is fully removed from the patient. In some instances, the device may be removed over other devices or instruments that may remain in the body. For example, the guidewire and/or instruments introduced into the body over the guidewire may remain in place. - In some instances,
steps steps method 820 are described elsewhere herein, and can include the layer engagement methods that use engagement arms that uniquely deploy radially and pass by each other during deployment. - In some instances,
step 807 may employ a threaded advancement methodology like that shown inFIGS. 20 and 21 , which can provides a controlled means for advancing thepuncture needle 301 and a means for theneedle 301 to stay in position when the user lets go. This type of advancement mechanism may, in some instances, limit the tactile feedback to the user of theneedle tip 302 as it is penetrating through tissue. -
FIGS. 27A and 27B depict another embodiment of atissue engagement device 821. Thedevice 821 includes a different mechanism for maintaining the puncture needle in a desired position. Thedevice 821 includes ahandle 820 havingmain body 822. InFIG. 27B , apuncture needle 823 is shown in channel orlumen 833. Atransverse slot 824 constrainsbrake pad 825 to have only back and forthmotion 827. Thebrake pad 825 has a slopedsurface 836 that faces theneedle 823.Knob 828 has a threadedshaft 829 that feeds into a threadedopening 832 so that asknob 828 is turned, it rotates aboutaxis 831, which creates the back and forth (e.g., transverse)motion 827.Brake pad 825 only moves in onedirection 827, which is preferably transverse to the deployment direction and long axis ofpuncture needle 823. In this way, then asbrake pad 825 presses againstneedle 823 it does not cause any additional unwanted motion of theneedle 823 along its deployment direction (e.g., in a direction into the page inFIG. 27B ). Thebrake pad 825 is connected to threadedshaft 829 so they stay together but the threadedshaft 829 can independently rotate withrotation motion 830 relative tobrake pad 825. Alternatively, thebrake pad 825 and the threadedshaft 829 may not be integrated into a single unit, but instead may be pressed together by placing a spring (not shown) at the end oftransverse slot 824. In this way, the spring (not shown) presses against the end ofbrake pad 825 and always biases it against the tip of threadedshaft 829. These are just two examples of a feature that allows a user to apply varying amounts of friction to theneedle 823. Other devices, mechanisms and techniques can be employed as well without deviating from the spirit and scope of the present disclosure. - The embodiments described above employ two engagement arms. However, other or further embodiments may have as few as 1 actuation arm or more than 2 actuation arms. In embodiments with more than 2 arms, the arms may be arranged in alternate, interleaving layers and may share common pivot pins or posts, or use different pivots. Further, the shapes, sizes and overall construct of the one or more engagement arms can vary depending on particular needs and applications.
- Moreover, the embodiments described above use a lever as an actuator. However, other forms of a user interface for moving the actuation rod are contemplated. Any suitable actuation mechanism may be employed, such as, for example, a knob, a sliding button, or any other suitable mechanical interface. Other suitable forms of actuation include pneumatic, electromechanical, or hydraulic for example. In general, any suitable actuation mechanism for transitioning the engagement arms between deployed and undeployed configurations are contemplated.
-
FIGS. 28A-30 illustrate yet another embodiment of atissue engagement device 901, which device includes ahandle 902, atube 903, and atip 904. Alever 905 extends frombody 911, and is used to actuateengagement arms tip 904. Whenlever 905 is angled towardtip 904, theengagement arms lever 905 is pivoted away fromtip 904, theengagement arms Needle assembly 950 attaches to handle 902 using a threaded coupling that joins handlethreads 940 with internal threads 960 (see FIG. 30) onadjustment dial 951. Thus, rotatingadjustment dial 951 causesneedle assembly 950 to advance forward or backward depending on the direction of rotation. A puncture needle 959 (FIG. 30 ) is attached toassembly 950 and passes through aneedle pathway 921 withintube 903. -
FIG. 29 is a detailed view ofhandle 902 andneedle assembly 950. Analignment rib 954 andneedle hub 952 are rigidly affixed (e.g., bonded or overmolded) topenetration needle 959.Needle hub 952 features luer lock threads by which a syringe can be attached toneedle assembly 950.Adjustment dial 951 is also fixed toassembly 950, but is not rotationally constrained and can freely spin.Alignment rib 954 is sized to slideably fit withinhandle slot 941 and acts to maintain the orientation ofneedle 959 asadjustment dial 951 is rotated. -
FIG. 30 is an exploded, detailed view ofhandle 902, withneedle assembly 950 separated fromhandle body 911.Needle 959 is affixed torib 954 andhub 952, and extends throughneedle passage 921 on connectingrod 920. -
FIG. 31 shows a cross sectional view ofhandle 902 andneedle assembly 950. The position ofneedle 959 relative to the other components ofassembly 950 can be readily seen in this view.Hub 952 is attached to the most proximal location of needle and ends at thefemale luer cavity 955. Ataper 956 fromcavity 955 provides a transition to ease the initial insertion of a guidewire (not shown). -
FIG. 32 is another view ofneedle assembly 950, shown in its entirety, including thebeveled tip 930 inneedle 959.FIG. 33 shows and exploded view ofneedle assembly 950 that illustrates a mechanism for rotationally indexing theadjustment dial 951. This is achieved with awave spring 965 that is positioned betweenrib 954 andinternal wall 966 ondial 951; and a set of angularly spaceddetents 967 and pockets 968.Spring 965 pushes dial 951 againsthub 952 such that when thedetents 967 andpocket 968 are aligned, thedial 951 is lightly held in position. By applying a suitable pitch on the threads 940 (shown inFIGS. 30 ) and 960, the indexing mechanism can assist the user in gauging the advancement distance of the needle tip. For example withindex positions 90 degrees apart, a thread pitch of 4 millimeters per revolution would mean that the needle advances 1 millimeter each time dial 951 is rotated to the next index stop. Fixed-distance markings onhandle 902 can provide additional indicators of the advancement distance ofneedle assembly 950. -
FIG. 34 illustrates another embodiment of anengagement arm 980 that is compatible with embodiments disclosed herein. In this design, theengagement arm 980 features a protrusion 981 (encircled by dotted circle) that provides additional advantageous properties. Theengagement arm 980 defines agap 982 with width BB and length DD. This arrangement can assist in controlling a penetration depth oftip 979 by limiting the amount of tissue that can fit into thegap 982. A height CC of theprotrusion 981 can further provide control by limiting the engagement oftip 979 into tissue prior to the actuation ofarm 980. Stated otherwise, theprotrusion 981 can inhibit thetip 979 from coming into contact with the target tissue layer prior to actuation of thearm 980. -
FIGS. 35A-35F depict adevice 1000 that includes theengagement arm 980 and anadditional engagement arm 990 of the same configuration (but flipped 180 degrees). These drawings depict various stages of deployment of thearms FIG. 35A ) to full actuation (FIG. 35D ). Deployment of apuncturing needle 1002 is shown inFIGS. 35D-35F , with the needle being fully retracted inFIG. 35D and fully deployed inFIG. 35F . In some instances, it can be preferable to fully deploy theengagement arms FIG. 35D prior to deploying theneedle 1002 in the manners shown inFIGS. 35D-35F . - As mentioned, the
engagement arm 990 can be identical to thearm 980, but may be flipped over such thattips arm 980 can lie alongsidearm 990, but in a mirrored orientation. In the orientation depicted inFIG. 35A , thearm tip 979 onarm 980 is opposed byprotrusion 991 onarm 990. For example, a distal edge of thetip 979 of thearm 980 can be substantially flush with a distal edge of theprotrusion 991 of thearm 990 in the illustrated orientation. Likewise, a distal edge of thetip 999 of thearm 990 can be substantially flush with a distal edge of theprotrusion 981 of thearm 980. Thus, it can be seen that theprotrusions device 1000 is applied against tissue in the illustrated orientation (e.g. in the retracted or undeployed state). - In the illustrated embodiment, the distal edges of the
tip 979 and theprotrusion 981 of thearm 980 are at approximately the same axial position at or near adistal end 1007 of thetube 1005. Similarly, the distal edges of thetip 999 and theprotrusion 991 of thearm 990 are at approximately the same axial position. In the illustrated embodiment, these edges are substantially flush with thedistal surface 1007 of thetube 1005. Such an arrangement can further control a manner and/or an amount of a tissue layer that can be received into agap 1009 or tissue receiving region. This can also control a manner in which portion of the tissue layer that is received therein is engaged as thearms FIGS. 35B-35E ). - As previously mentioned,
FIG. 35D shows thearms puncture needle 102. Thedevice 1000 can include anactuation rod 1010 that can effect deployment of thearms actuation rod 1010 can define a channel orlumen 1012 within which theneedle 1002 is carried. In the illustrated embodiment, theactuation rod 1010 can be advanced distally independent of theneedle 1002. Once theactuation rod 1010 has completed deployment of thearms needle 1002 can be advanced distally through thechannel 1012. Theneedle 1002 can be advanced beyond the distal end of theactuation rod 1010, as shown inFIG. 35F . - In some instances the
protrusions FIG. 35D . In such circumstances, the additional material ofprotrusions device 1000 is well suited. Yet another advantage is that the protrusions can act as safety guards by shielding the tip points (e.g. tip 979 of arm 980). For example, if the device is withdrawn while the arms are inadvertently actuated, the protrusions will minimize unintended tissue trauma by diverting tissue away and around thetips device 1000. In some instances, theprotrusions protrusions - In some instance, the ability to rapidly retract the needle during the procedure—after delivery of the guidewire, for example—may be desired by the user.
FIG. 36 depicts an example of a rapid retraction mechanism, adapted to the threaded coupling between theneedle assembly 950 and thedevice handle 902. Here, handlethreads 940 are located on aslideable segment 945 which can be displaced inwardly by applying a pinching force alongdirection 946. During normal use, internal springs (not visible) apply an outward biasing force that maintains engagement betweenhandle threads 940 and dialthreads 960. Thus,needle assembly 950 can be quickly disengaged and removed by applying the pinching force alongdirection 946 and retractingassembly 950. Additionally a biasing element, such as a coil spring, may be inserted betweenneedle assembly 950 and handle 902 such thatneedle assembly 950 is urged away during retraction. - Referring to
FIG. 37 , another accessory feature for assisting with user handling of the device is described.FIG. 37 illustrates a slideable andlockable collar 961 that fits overtube 903. Means for lockingcollar 961 totube 903 include friction, collets, clamping or other common means for fixing an object axially mounting on a shaft. In some instances, after a user has successfully actuated engagement arms (in thisembodiment 980 and 990), and applied traction to the soft tissue, the user may wish to maintain such traction while performing further steps, such as insertion of the guidewire. Rather than manually holding such traction,collar 961 may be slid distally alongtube 903 until it is against the patient's skin. Thencollar 961 may be locked in position against the skin. This will maintain the traction on the soft tissue, and frees the user's hand for performing subsequent steps of a procedure. - In the embodiment shown in
FIG. 37 , theshaft 903 ofdevice 901 slides intolockable collar 961. However,lockable collar 961 may have an opening along its length so that it can be slipped onto theshaft 903 ofdevice 901 and taken off without having to slide the device throughlockable collar 961. This can be advantageous if, for example, thelockable collar 961 is to be removed while thedevice 901 is inserted in a patient. - Embodiments have been described herein in the context of pericardial access, but discussion of this context should not be considered limiting as other uses and applications are contemplated. For example, some embodiments are used in endoscopic third ventriculostomy (ETV), which requires lifting the floor of the third ventricle from the underlying tissue to be able to create a hole through it. Another exemplary application is in laparascopic access into the peritoneal space that requires pulling tissue layers, such as peritoneum, from underlying tissue layers or organs. The device and techniques disclosed herein can be further used in various other applications and procedures.
- Advantageously, embodiments described herein have features, geometry, and structure that allow the tissue engagement devices to be mass produced cost effectively. Preferred manufacturing methods for the main components include metal stamping, plastic molding, machining, and laser cutting. Other manufacturing methods known to those of ordinary skill in the art are also contemplated.
- The present invention has now been described with reference to several illustrative embodiments thereof. The foregoing disclosure has been provided for clarity of understanding by those skilled in the art. No unnecessary limitations should be taken from the foregoing disclosure. It will be apparent to those skilled in the art that changes can be made in the illustrative embodiments described herein without departing from the scope of the present invention. Thus, the scope of the present invention should not be limited to the illustrative structures and methods described herein, but only by the structures and methods described by the language of the claims and the equivalents of those claimed structures and methods.
- Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.
- References to approximations are made throughout this specification, such as by use of the terms “about” or “approximately.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about,” “substantially,” and “generally” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially flush” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely flush orientation.
- Any reference throughout this specification to “certain embodiments” or the like means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment or embodiments.
- Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.
- The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.
- Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements specifically recited in means-plus-function format, if any, are intended to be construed in accordance with 35 U.S.C. § 112(f). Embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows.
Claims (24)
1. A tissue engagement device comprising:
a tube that defines a lumen having a maximum interior width;
an actuation rod positioned within the lumen of the tube;
a plurality of arms, each arm comprising a piercing tip; and
an actuator configured to move the actuation rod relative to the tube to rotate the arms between (i) a retracted orientation in which the tips of adjacent arms are at a distance from each other that is less than the maximum interior width of the lumen and (ii) an actuated orientation in which the tips of adjacent arms are directed away from each other and are spaced from each other by a distance that is greater than the maximum interior width,
wherein, when a distal end of the tissue engagement device abuts a layer of tissue, actuation of the arms via the actuator rotates the tips into the layer of tissue to pierce the layer of tissue and to apply tension to the layer of tissue outwardly in opposite directions, and
wherein the piercing tips of the arms are positioned distally beyond a distal face of the tube when the arms are in the retracted orientation.
2. The tissue engagement device of claim 1 , wherein the tips of the arms face away from each other when the tissue engagement device is in the retracted orientation.
3. The tissue engagement device of claim 1 , wherein the actuation rod comprises a tip at a distal end thereof, and wherein the piercing tips of the arms extend distally past the distal tip of the actuation rod during at least a portion of a transition of the arms from the retracted orientation to the actuated orientation.
4. The tissue engagement device of claim 1 , wherein the piercing tips of the arms extend distally past the distal face of the tube during at least a portion of a transition of the arms from the retracted orientation to the actuated orientation.
5. The tissue engagement device of claim 1 , wherein at least a portion of each arm is positioned distally relative to the distal face of the tube throughout a transition of the arms from the retracted orientation to the actuated orientation.
6. The tissue engagement device of claim 1 , wherein the arms are pivotally coupled either to the tube or to the actuation rod.
7. The tissue engagement device of claim 1 , further comprising a puncture needle that comprises a tip configured to puncture through a tissue layer after the tissue layer has been engaged by the arms.
8. The tissue engagement device of claim 7 , wherein the actuation rod defines a needle pathway through which the puncture needle passes.
9. The tissue engagement device of claim 8 , wherein the needle pathway is either parallel to or collinear with a central axis of the tube.
10. The tissue engagement device of claim 8 , wherein the needle pathway extends between the arms.
11. The tissue engagement device of claim 7 , further comprising a fitting attached to the proximal end of the puncture needle, the fitting comprising a Luer connection interface.
12. The tissue engagement device of claim 1 , wherein the actuator comprises a lever, a knob, or a sliding button.
13. The tissue engagement device of claim 1 , wherein the actuation rod is moved distally relative to the tube to transition the arms from the retracted orientation to the actuated orientation.
14. The tissue engagement device of claim 1 , wherein the piercing tips of the arms are configured to embed within or otherwise engage the pericardium of a heart without passing through the pericardium of the heart when the arms are transitioned from the retracted orientation to the actuated orientation.
15. The tissue engagement device of claim 1 , wherein the piercing tips of the arms are configured to move only in transverse and proximal directions relative to the tube when the arms are transitioned from the retracted orientation to the actuated orientation.
16. The tissue engagement device of claim 1 , wherein the piercing tips of the arms move in unison with each other along oppositely directed paths as the arms are transitioned from the retracted orientation to the actuated orientation.
17. The tissue engagement device of claim 1 , wherein the piercing tips of the arms are at the distal end of the tissue engagement device when the arms are in the retracted orientation.
18. The tissue engagement device of claim 1 , wherein the actuation rod comprises a tip at the distal end of the tissue engagement device, wherein the tip of the actuation rod is recessed relative to the distal face of the tube when the arms are in the retracted orientation.
19. The tissue engagement device of claim 1 , wherein the piercing tips of the arms are each sharpened along one or more bevel planes.
20. A tissue engagement device comprising:
a tube that defines a lumen having a maximum interior width;
an actuation rod configured to be positioned within the lumen of the tube, the actuation rod defining a needle pathway;
a plurality of arms, each arm comprising a piercing tip;
an actuator configured to move the actuation rod relative to the tube to transition the arms between (i) a retracted orientation in which the tips of adjacent arms are at a distance from each other that is less than the maximum interior width of the lumen and (ii) an actuated orientation in which the tips of adjacent arms are directed away from each other and are spaced from each other by a distance that is greater than the maximum interior width; and
a needle configured to pass through the needle pathway of the actuation rod while the arms are in the actuated orientation,
wherein, when a distal end of the tissue engagement device abuts a layer of tissue, actuation of the arms via the actuator introduces the tips into the layer of tissue to engage the layer of tissue and to apply tension to the layer of tissue outwardly in opposite directions,
wherein, proximal movement of the tissue engagement device when the arms are in the actuated orientation and engage the layer of tissue causes the layer of tissue to lift away from underlying tissue, and
wherein the needle pathway is oriented to direct a distal end of the needle to puncture through the layer of tissue as the needle is advanced distally through the needle pathway while the layer of tissue remains lifted away from the underlying tissue.
21. The tissue engagement device of claim 20 , wherein the needle pathway is collinear with a central axis of the tube.
22. The tissue engagement device of claim 20 , wherein the needle pathway extends between the arms when the arms are in the actuated orientation.
23. A tissue engagement device comprising:
a tube that defines a lumen having a maximum interior width;
an actuation rod configured to be positioned within the lumen of the tube, the actuation rod defining a needle pathway;
a plurality of arms, each arm comprising a piercing tip;
an actuator configured to move the actuation rod relative to the tube to transition the arms between (i) a retracted orientation in which the tips of adjacent arms are at a distance from each other that is less than the maximum interior width of the lumen and (ii) an actuated orientation in which the tips of adjacent arms are directed away from each other and are spaced from each other by a distance that is greater than the maximum interior width; and
a needle configured to pass through the needle pathway of the actuation rod,
wherein the needle pathway extends between the arms when the arms are in the actuated orientation.
24. The tissue engagement device of claim 23 , wherein the needle pathway extends between the arms when the arms are in the retracted orientation.
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US17/494,816 US20220022907A1 (en) | 2015-01-20 | 2021-10-05 | Tissue engagement devices, systems, and methods |
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US15/002,349 US20160206338A1 (en) | 2015-01-20 | 2016-01-20 | Tissue engagement devices, systems, and methods |
US16/149,371 US20190269428A1 (en) | 2015-01-20 | 2018-10-02 | Tissue engagement devices, systems, and methods |
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Also Published As
Publication number | Publication date |
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US20160206338A1 (en) | 2016-07-21 |
EP3247291B1 (en) | 2021-04-14 |
WO2016118616A1 (en) | 2016-07-28 |
US20220022907A1 (en) | 2022-01-27 |
EP3247291A1 (en) | 2017-11-29 |
EP3865081A1 (en) | 2021-08-18 |
EP3247291A4 (en) | 2018-08-29 |
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