Biopsy site tissue repair device and method

Abstract

A device for delivering a biocompatible patch material to a biological site, the device comprising: a housing having a cocking mechanism, an actuation button for releasing the cocking mechanism, and a needle cartridge recess; and a needle cartridge removably received in the needle cartridge recess of the housing, the needle cartridge comprising a storage cell containing the biocompatible patch material and a needle having a lumen in fluid communication with the storage cell, wherein when the needle cartridge is received in the needle cartridge recess, the needle cartridge is mechanically coupled to the cocking mechanism such that operation of the actuation button dispenses the biocompatible patch material from a distal end of the needle.

Description

[Technical field]

[0001] cross reference This application claims the benefit of U.S. Provisional Patent Application No. 63 / 272,997, filed October 28, 2021, U.S. Provisional Patent Application No. 63 / 319,195, filed March 11, 2022, U.S. Provisional Patent Application No. 63 / 397,250, filed August 11, 2022, and U.S. Provisional Patent Application No. 63 / 413,161, filed October 4, 2022, the entireties of which are incorporated by reference herein. [Background technology]

[0002] Despite previous attempts at improving the safety of biopsies, endoscopies, and various other surgical procedures, current and prior art techniques are unable to effectively prevent major bleeding and other major complications. Many of these procedures, while routine in nature, pose significant risks even to otherwise healthy individuals.

[0003] Moreover, even when these procedures can provide treatment-guiding information that can save lives, the risk of complications prevents their use. The risk factors for these problems can be intrinsic (e.g., concurrent diseases), extrinsic (e.g., anticoagulant drugs), or both, and are often complex in nature. In the case of renal diseases, for example, disease etiologies frequently overlap or progress rapidly. This necessitates clinicians to perform renal biopsy procedures to obtain diagnostic and treatment-guiding information. However, the majority of these patients have abnormalities in the functioning of the coagulation system, elevated blood pressure, lesions of vulnerable organ tissues, and suffer from concurrent cardiac disease or vascular fibrosis. These risk factors limit renal biopsy procedures to a fraction of their indicated uses, preventing patients from obtaining the therapeutic benefits that can be derived from them, and incurring high costs of morbidity and mortality. The same is true for liver, neoplastic, neurological, and gastrointestinal diseases, among others.

[0004] Patients with mild to moderate disease are also at substantial risk for these complications. Ten percent of liver or kidney biopsy patients experience significant bleeding, requiring blood transfusions and prolonged hospitalization. The risks after kidney biopsy are so high that over 50% of cases are followed up, even in relatively young patients without any comorbidities. The safety profile of many other types of needle or biopsy-based procedures also has unacceptable complication rates. Prostate biopsies cause residual rectal bleeding in 33% of cases, brain biopsies cause significant intracranial bleeding in 5-10% of cases, and gastrointestinal / pancreatic / and thoracic procedures all have a high inherent risk of complications.

[0005] In renal biopsies, all three components of the coagulation system are compromised during disease progression. High tensile strength packings do not prevent external bleeding, especially in individuals with severe hypertension. Plugging without occlusion also places these renal and hepatic disease patients at higher risk for delayed bleeding. Although occlusion may hold up for a period of time, high internal and external adhesion is a better means to prevent cracking or failure of the internal patch and propagation of cracks that may otherwise propagate along the interface closure between the patch material and the tissue.

[0006] The devices described in this application solve numerous previously unrecognized physiological and pathophysiological challenges that make organs susceptible to bleeding or other complications during instrumentation. The device embodiments presented herein use one or more means for rapid or immediate closure of some or all of the damaged edges, biological tissues, organs, blood vessels, light-emitting structures, and materials. Summary of the Invention

[0007] In some embodiments, the device is designed to rapidly close biological tissues, structures, organs, vessels, and other biological structures. In some embodiments, the device is designed to simultaneously or sequentially close damaged tissue while performing a biopsy sample collection procedure. In some embodiments, this is accomplished using one or more means including patch materials, thermal cauterization, RF electrosurgery, acoustic ultrasonic ablation, freezing, plugging, or other methods described herein.

[0008] In some embodiments, the patch material is a photopolymerized material. In some embodiments, these photopolymerized patch materials are made from dual networks of molecules that contain multiple types of monomers, mixtures, or materials. In some embodiments, the device is designed to rapidly activate the highly adherent photopolymerized patch material. In some embodiments, the patch material does not rely on photopolymerization to occlude biological material.

[0009] In some embodiments, the RF electrosurgery used to close the tissue is monopolar in nature, bipolar in nature, or of some variety. In some varieties of embodiments, a combination of patch materials is used before, during, or after the use of any one of the other tissue modification methods. In some embodiments, the device includes the use of a combination of RF electrosurgery and the placement of a light-activated patch material. In some embodiments, the device uses one or more synthetic patch materials, natural patch materials, patch materials that do not require light activation, other patch materials disclosed herein, or any combination thereof. In some embodiments, acoustic or thermal ablation is used in combination with the placement of a patch material. In some embodiments, acoustic or thermal ablation is used in combination with the placement and activation of a light-polymerized patch material.

[0010] In some embodiments, the device emits photons from one or more functional ends to activate a photosensitive material utilized as a biocompatible patch material. In some embodiments, this may be used for one or more of wound closure, tissue closure, blood vessel closure, tubular structure closure, hemorrhage prevention, blood clotting, fluid outflow prevention, defect repair, tubular body creation, tubular body repair, tubular body lumen modification, or other suitable uses, and combinations thereof. In some embodiments, the device emits photons from one or more of the following parts of the device: needle body, shaft, interior, exterior, tip, and / or through the cutting end and / or other parts of the body, and through the interior and / or exterior surfaces.

[0011] In some embodiments of the device, there is a device housing. In some embodiments herein, the proximal side of the device refers to the portion of the device away from the tip used on the patient, animal, or target tissue. In some embodiments herein, the distal side of the device refers to the tip or portion of the device away from the device used at the biological site on the patient, animal, or target tissue. In some embodiments of the device, a biocompatible patch material containing a light-activated (or light-initiated) substance (or mixture) is released from the distal portion of the device into a biopsy specimen cavity, a biopsy tract, a biopsy area, a puncture tract, an instrumented tissue, an injured area, a lacerated area, a wound, a feeding, a surgical site, a blood vessel, a nerve, an injured tissue, a central nervous system tract, a kidney tissue, a liver tissue, a prostate tissue, a brain tissue, a breast tissue, a tumor tissue, a mass tissue, a lung, a heart, an area of ​​blunt trauma, an area of ​​abrasion, or any other biological tissue area. The site may also be referred to herein as a biological site, a tissue repair site, or a biological repair site. In some embodiments, the substance prevents bleeding, vascular damage, vascular malformation, saliva extrusion, bile extrusion, fecal extrusion, cerebrospinal fluid extrusion, urine extrusion, or any other biological material. In some embodiments, the substance is applied to one or more of the following locations: on the medical device, adjacent to the medical device, some distance from the medical device, biopsy location, biopsy path, instrumentation path. In some embodiments, photoinitiation of the biocompatible patch material is performed by photons emitted from one or more of the following locations: needle tip, needle shaft, catheter, sheath, wave guide, light diffuser, light projector, lamp, laser, housing of the device, biopsy portion of the device, moving portion of the device, stationary portion of the device, some other aspect of the device, or combinations thereof.

[0012] In some embodiments, the device is intended for use in one or more of the following types of biopsy procedures: fine needle aspiration biopsy, core needle biopsy, suction biopsy, needle biopsy, cryobiopsy, vibrating needle biopsy, biopsy gun, spring-loaded biopsy, actuator-activated biopsy, pneumatically controlled biopsy, thermal biopsy, electrocautery biopsy, cryo-biopsy, automated biopsy, hydraulic biopsy, multiple needle biopsy, multiple pass biopsy, among others. In some embodiments, the device is intended for use during one or more of the following procedures: surgical, endoscopic, colonoscopic, bronchoscopy, vascular, angioplasty, biopsy, arterial, sinus, transplant, fistula, neurosurgical, cardiovascular, urological, renal, breast, pulmonary, gastrointestinal.

[0013] In some embodiments, the device is intended for use with one or more organs, tissues, biological fluids, biological structures, biological matter, and / or other biological materials. In some embodiments, one or more of the organs, structures, and / or materials are all and / or a portion of the head, brain, subarachnoid space, outer ear, inner ear, middle ear, sinuses, face, nasal cavity, oral cavity, oropharyngeal cavity, in or the neck, spine, chest, lungs, heart, trachea, bronchioles, lungs, abdomen, kidneys, liver, blood vessels, nerves, arteries, aorta, esophagus, stomach, small intestine, bladder, large intestine, bone, central nervous system, cornea, eye, biliary tract, fistula, ulcer, acute wound, tubular body, chronic wound, pancreas, abdomen, legs, feet, arms, hands, gastrointestinal, rectum, skin, nervous system, peripheral nerves, hands, feet, lower legs, fingers, toes, eyes, and / or any other portion of a tissue, organ, cell, biological material, or biological material.

[0014] In some embodiments, the device is used for performing a wide needle biopsy, fine needle biopsy, needle insertion, arterial wound, arterial hemostasis, surgical hemostasis, vascular ligation, arterial ligation, fallopian tube ligation, lumbar puncture, CNS instrumentation, eye surgery, ear surgery, ENT surgery, tonsillectomy, sinus surgery, neurosurgery, ligated tissue, surgical wound treatment, traumatic wound treatment, mass treatment, stenting of arteries, stenting of veins, stenting of lymphatic vessels, stenting of cerebrospinal fluid pathways, bile duct repair, stenting, stenting of pancreatic ducts, stenting of tubular structure injury, stenting of blood vessels with thermal or radiation injury or injury associated with wound, stenting of vascular tubular structures with malignant infiltration. In one embodiment, the present invention contemplates performing, assisting, treating, covering, closing, closing a pathway, aiding in the repair, or a combination of one or more of the following procedures: stenting of the aorta, stenting of arteries affected by peripheral arterial sclerosis, stenting of cerebral vasculature, stenting of previously stenotic areas, stenting of previously stented areas, stenting of vessels or tubular structures damaged by penetrating trauma, stenting of vessels or tubular structures damaged by blunt trauma, and / or stenting of vessels or tubular structures damaged by blast or pneumatic injury.

[0015] In some embodiments, the device is used for biopsy such that the needle portion of the device conducts, propagates, and / or generates photons which are propagated to the photoactivated material, thereby causing one or more of the following effects: tissue closure, cell closure, tubular structure closure, blood vessel closure, artery closure, coagulation, liquefaction, hardening, softening, gelling, increasing viscosity, decreasing viscosity, increasing thickness, decreasing thickness, increasing elasticity, decreasing elasticity, increasing stiffness, decreasing stiffness, increasing flexibility, decreasing flexibility, increasing flexibility, decreasing flexibility, increasing adhesion, decreasing adhesion, maintaining shape, releasing shape, relaxing shape, solidifying surrounding structures, softening surrounding structures, fixing the relative and / or absolute position of one or more surrounding structures, fixing the relative and / or absolute position within its internal lumen and / or interior cavity.

[0016] INCORPORATION BY REFERENCE All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. [Brief description of the drawings]

[0017] The novel features of the invention are set forth with particularity in the appended claims. To better understand the nature and advantages of the present invention, reference should be made to the following detailed description that sets forth illustrative embodiments in which the principles of the invention are utilized and the accompanying drawings.

[0018] [Figure 1A] 1 illustrates a device for collecting a tissue specimen and repairing tissue at a biopsy site, according to some embodiments. [Figure 1B] 1 illustrates a device for collecting a tissue specimen and repairing tissue at a biopsy site, according to some embodiments. [Figure 1C] 1 illustrates a device for collecting a tissue specimen and repairing tissue at a biopsy site, according to some embodiments. [Figure 1D] 1 illustrates a device for collecting a tissue specimen and repairing tissue at a biopsy site, according to some embodiments. [Figure 1E] 1 illustrates a device for collecting a tissue specimen and repairing tissue at a biopsy site, according to some embodiments. [Figure 1F] 1 illustrates a device for collecting a tissue specimen and repairing tissue at a biopsy site, according to some embodiments. [Figure 1G] 1 illustrates a device for collecting a tissue specimen and repairing tissue at a biopsy site, according to some embodiments. [Figure 2A] 1 illustrates various components of a tissue repair device, according to several embodiments. [Figure 2B] 1 illustrates various components of a tissue repair device, according to several embodiments. [Figure 2C]1 illustrates various components of a tissue repair device, according to several embodiments. [Figure 2D] 1 illustrates various components of a tissue repair device, according to several embodiments. [Figure 3A] 1 illustrates a waveguide for propagating light through a lumen of a biopsy needle, according to some embodiments. [Figure 3B] 1 illustrates a waveguide for propagating light through the lumen of a biopsy needle, according to some embodiments. [Figure 3C] 1 illustrates a waveguide for propagating light through the lumen of a biopsy needle, according to some embodiments. [Figure 3D] 1 illustrates a waveguide for propagating light through the lumen of a biopsy needle, according to some embodiments. [Figure 3E] 1 illustrates a waveguide for propagating light through the lumen of a biopsy needle, according to some embodiments. [Figure 4A] 1 illustrates a retractable optical rod for curing dispensed light-polymerized biocompatible patch material at a tissue repair site, according to some embodiments. [Figure 4B] 1 illustrates a retractable optical rod for curing dispensed light-polymerized biocompatible patch material at a tissue repair site, according to some embodiments. [Figure 4C] 1 illustrates a retractable optical rod for curing dispensed light-polymerized biocompatible patch material at a tissue repair site, according to some embodiments. [Figure 4D] 1 illustrates a retractable optical rod for curing dispensed light-polymerized biocompatible patch material at a tissue repair site, according to some embodiments. [Figure 4E] 1 illustrates a retractable optical rod for curing dispensed light-polymerized biocompatible patch material at a tissue repair site, according to some embodiments. [Figure 5A] 1 illustrates a rotatable sheath for obtaining a tissue sample during a biopsy, according to some embodiments. [Figure 5B]1 illustrates a rotatable sheath for obtaining a tissue sample during a biopsy, according to some embodiments. [Figure 5C] 1 illustrates a rotatable sheath for obtaining a tissue sample during a biopsy, according to some embodiments. [Figure 5D] 1 illustrates a rotatable sheath for obtaining a tissue sample during a biopsy, according to some embodiments. [Figure 6A] A catheter-deliverable device for collecting tissue and repairing tissue at a biopsy site, according to some embodiments. [Figure 6B] A catheter-deliverable device for collecting tissue and repairing tissue at a biopsy site, according to some embodiments. [Figure 6C] A catheter-deliverable device for collecting tissue and repairing tissue at a biopsy site, according to some embodiments. [Figure 6D] A catheter-deliverable device for collecting tissue and repairing tissue at a biopsy site, according to some embodiments. [Figure 7A] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 7B] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 7C] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 7D] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 8A] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 8B] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 8C] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 8D] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 8E]1 illustrates a device for repairing tissue, according to some embodiments. [Figure 9A] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 9B] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 9C] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 10A] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 10B] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 10C] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 10D] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 10E] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 11A] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 11B] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 11C] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 11D] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 12A] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 12B] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 12C] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 12D] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 12E] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 12F] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 13A] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 13B] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 13C] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 13D] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 13E] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 14A] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14B] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14C] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14D] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14E] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14F] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14G] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14H] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14I] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14J] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14K] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 14L] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 15A] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 15B] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 15C] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 15D] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 15E] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 15F] 1 illustrates components of a cocking mechanism of a device for tissue repair, according to some embodiments. [Figure 16A] 1 illustrates components of a device for repairing tissue, according to some embodiments. [Figure 16B] 1 illustrates components of a device for repairing tissue, according to some embodiments. [Figure 16C] 1 illustrates components of a device for repairing tissue, according to some embodiments. [Figure 16D]1 illustrates components of a device for repairing tissue, according to some embodiments. [Figure 17A] 1 illustrates a detachable light source of a device for tissue repair, according to some embodiments. [Figure 17B] 1 illustrates a detachable light source of a device for tissue repair, according to some embodiments. [Figure 17C] 1 illustrates a recess for accommodating a removable light source of a device for tissue repair, according to some embodiments. [Figure 17D] 1 illustrates a recess for accommodating a removable light source of a device for tissue repair, according to some embodiments. [Figure 18A] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 18B] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 18C] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 18D] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 18E] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 19A] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 19B] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 19C] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 19D] 1 illustrates a needle cartridge component of a device for repairing tissue, according to some embodiments. [Figure 20A]1 illustrates a needle cartridge component of a device for repairing tissue during delivery of a biocompatible patch material, according to some embodiments. [Figure 20B] 1 illustrates a needle cartridge component of a device for repairing tissue during delivery of a biocompatible patch material, according to some embodiments. [Figure 20C] 1 illustrates a needle cartridge component of a device for repairing tissue during delivery of a biocompatible patch material, according to some embodiments. [Figure 20D] 1 illustrates a needle cartridge component of a device for repairing tissue during delivery of a biocompatible patch material, according to some embodiments. [Figure 21A] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 21B] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 21C] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 21D] 1 illustrates a device for repairing tissue, according to some embodiments. [Figure 22A] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 22B] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 22C] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 22D] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 23A] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 23B] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 23C]1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 23D] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 24A] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 24B] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 24C] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 24D] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 24E] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 25A] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 25B] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 25C] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 25D] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 25E] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 26A] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 26B] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 26C]1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 27A] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 27B] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 27C] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 28A] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Figure 28B] 1 illustrates a method for using a device for repairing tissue, according to some embodiments. [Figure 29] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Diagram 30] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Diagram 31] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Diagram 32] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Diagram 33] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Diagram 34] 1 illustrates one or more fluid-handling components of an apparatus for repairing tissue, according to some embodiments. [Diagram 35] 1 illustrates an automatic needle retraction component of a device for tissue repair, according to some embodiments. [Figure 36A] 1 illustrates a needle retraction component of a device for repairing tissue, according to some embodiments. [Figure 36B]1 illustrates a needle retraction component of a device for repairing tissue, according to some embodiments. [Figure 37A] 1 illustrates an automatic light source toggle component of an apparatus for repairing tissue during delivery of a biocompatible patch material, according to some embodiments. [Figure 37B] 1 illustrates an automatic light source toggle component of an apparatus for repairing tissue during delivery of a biocompatible patch material, according to some embodiments. [Figure 38] 1 illustrates a sterile sleeve for containing at least a portion of a device for repairing tissue using cauterization, according to some embodiments. [Figure 39A] 1 is a component of a tissue repair device, according to some embodiments. [Figure 39B] 1 is a component of a tissue repair device, according to some embodiments. [Figure 39C] 1 is a component of a tissue repair device, according to some embodiments. [Figure 39D] 1 is a component of a tissue repair device, according to some embodiments. [Figure 40A] 1 illustrates a method of using a tissue repair device comprising a balloon to provide compression during tissue repair, according to some embodiments. [Figure 40B] 1 illustrates a method of using a tissue repair device comprising a balloon to provide compression during tissue repair, according to some embodiments. [Figure 40C] 1 illustrates a method of using a tissue repair device comprising a balloon to provide compression during tissue repair, according to some embodiments. [Figure 40D] 1 illustrates a method of using a tissue repair device comprising a balloon to provide compression during tissue repair, according to some embodiments. [Figure 40E] 1 illustrates a method of using a tissue repair device comprising a balloon to provide compression during tissue repair, according to some embodiments. [Diagram 40F] 1 illustrates a method of using a tissue repair device comprising a balloon to provide compression during tissue repair, according to some embodiments. [Figure 41A] 1 illustrates a method of using a tissue repair device with a retractable light source to repair a biopsy site, according to some embodiments. [Figure 41B] 1 illustrates a method of using a tissue repair device with a retractable light source to repair a biopsy site, according to some embodiments. [Figure 41C] 1 illustrates a method of using a tissue repair device with a retractable light source to repair a biopsy site, according to some embodiments. [Figure 41D] 1 illustrates a method of using a tissue repair device with a retractable light source to repair a biopsy site, according to some embodiments. [Figure 41E] 1 illustrates a method of using a tissue repair device with a retractable light source to repair a biopsy site, according to some embodiments. [Fig.41F] 1 illustrates a method of using a tissue repair device with a retractable light source to repair a biopsy site, according to some embodiments. [Figure 42A] 1 illustrates a method of partially photoactivating a biocompatible patch material using a tissue repair device with a stretchable light source, according to some embodiments. [Figure 42B] 1 illustrates a method of partially photoactivating a biocompatible patch material using a tissue repair device with a stretchable light source, according to some embodiments. [Figure 42C] 1 illustrates a method of partially photoactivating a biocompatible patch material using a tissue repair device with a stretchable light source, according to some embodiments. [Fig.42D] 1 illustrates a method of partially photoactivating a biocompatible patch material using a tissue repair device with a stretchable light source, according to some embodiments. [Figure 42E] 1 illustrates a method of partially photoactivating a biocompatible patch material using a tissue repair device with a stretchable light source, according to some embodiments. [Figure 43A]1 illustrates a method of repairing a biopsy site using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Figure 43B] 1 illustrates a method of repairing a biopsy site using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Figure 43C] 1 illustrates a method of repairing a biopsy site using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Fig. 43D] 1 illustrates a method of repairing a biopsy site using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Figure 43E] 1 illustrates a method of repairing a biopsy site using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Figure 43F] 1 illustrates a method of repairing a biopsy site using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Figure 44A] 1 illustrates a method of repairing a biopsy site by depositing material anchors using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Figure 44B] 1 illustrates a method of repairing a biopsy site by depositing material anchors using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Figure 44C] 1 illustrates a method of repairing a biopsy site by depositing material anchors using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Fig.44D] 1 illustrates a method of repairing a biopsy site by depositing material anchors using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Figure 44E] 1 illustrates a method of repairing a biopsy site by depositing material anchors using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Fig.44F]1 illustrates a method of repairing a biopsy site by depositing material anchors using a tissue repair device comprising a light emitting catheter, according to some embodiments. [Figure 45A] 1 illustrates a method of repairing a biopsy site with ablation using a tissue repair device, according to some embodiments. [Figure 45B] 1 illustrates a method of repairing a biopsy site with ablation using a tissue repair device, according to some embodiments. [Figure 45C] 1 illustrates a method of repairing a biopsy site with ablation using a tissue repair device, according to some embodiments. [Figure 45D] 1 illustrates a method of repairing a biopsy site with ablation using a tissue repair device, according to some embodiments. [Figure 45E] 1 illustrates a method of repairing a biopsy site with ablation using a tissue repair device, according to some embodiments. [Figure 46A] 1 illustrates a method of using a tissue repair device to repair a biopsy site with ablation and delivery of a biocompatible patch material, according to some embodiments. [Figure 46B] 1 illustrates a method of using a tissue repair device to repair a biopsy site with ablation and delivery of a biocompatible patch material, according to some embodiments. [Figure 46C] 1 illustrates a method of using a tissue repair device to repair a biopsy site with ablation and delivery of a biocompatible patch material, according to some embodiments. [Figure 46D] 1 illustrates a method of using a tissue repair device to repair a biopsy site with ablation and delivery of a biocompatible patch material, according to some embodiments. [Figure 46E] 1 illustrates a method of using a tissue repair device to repair a biopsy site with ablation and delivery of a biocompatible patch material, according to some embodiments. [Figure 47A] 1 illustrates a plate capable of propagating ultrasound, according to some embodiments. [Figure 47B] 1 illustrates a plate capable of propagating ultrasound, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Provided herein are embodiments of a device for repairing tissue by delivering a biocompatible patch material to a target site. In some embodiments, the biocompatible patch material is activated, causing a phase or viscosity change. In some embodiments, the patch material is light activated. In some embodiments, the patch material is not light activated, but is still capable of hemostasis of hydrostatic bleeding at the arterial level. In some embodiments, the device is capable of hemostasis of arterial bleeding with a combination of tissue modification mechanisms and patch material delivery.

[0020] I. Biocompatible Patches In some embodiments, the device delivers and activates a biocompatible patch material to one or more of an organ, tissue, blood vessel, artery, lumen, vein, nerve, lumen, skin, mucosa, duct, lymphatic tissue, muscle, bone, biological surface, biological interface, tubular body, other biological material, or any combination thereof. In some embodiments, the device comprises components, substances, and controls to deliver and activate the patch material to one or more biological locations. In some embodiments, the biological location is instrumented in association with one or more of a biopsy site, biopsy wound, biopsy tract, puncture tract, surgical tract, vascular ligation, arterial ligation, instrumented tissue, vascular procedure, endoscopic procedure, hemostatic procedure, bronchoscopy procedure, gastrointestinal procedure, wound treatment, traumatic wound, ulceration, fistula treatment, surgical wound treatment, acute wound treatment, chronic wound treatment, other surgical procedure, or any combination thereof. In some embodiments, the device delivers patch material to these areas to close in combination with one or more procedures including, but not limited to, large needle biopsy, fine needle biopsy, fine needle aspiration, vacuum assisted biopsy, one-handed biopsy, RF electrosurgery, hemostatic procedures, tissue closure procedures, or any combination thereof.

[0021] In some embodiments, the device can be used to effectively excise and remove biopsy specimens from internal organs such as the liver or kidney, while simultaneously delivering and curing a biocompatible light-polymerizing patch material to areas of altered tissue and biological material by instrumentation. In some embodiments, the patch material is activated by light polymerization to create an adhesion force (internal, external, or both) that exceeds the hydrostatic blood pressure of a hypertensive human. In some embodiments, the device and patch material are designed to confine the cure, action, and / or function of the occlusive patch material to one or more target locations.

[0022] In some embodiments, the device may perform one or more of these functions and simultaneously perform another tissue modification treatment, such as RF electrosurgery as described herein, ultrasonic (US) vibration ablation, thermal ablation, some other tissue modification treatment, or some combination thereof.

[0023] In some embodiments, the light-activated patch material withstands hydrostatic pressures of about 120 mmHg to about 300 mmHg. In some embodiments, the light-activated patch material withstands hydrostatic pressures of about 120 mmHg to about 130 mmHg, about 120 mmHg to about 140 mmHg, about 120 mmHg to about 200 mmHg, about 120 mmHg to about 250 mmHg, about 120 mmHg to about 300 mmHg, about 130 mmHg to about 140 mmHg, about 130 mmHg to about 200 mmHg, about 13 The photoactivated patch material withstands a hydrostatic pressure of about 0 mmHg to about 250 mmHg, about 130 mmHg to about 300 mmHg, about 140 mmHg to about 200 mmHg, about 140 mmHg to about 250 mmHg, about 140 mmHg to about 300 mmHg, about 200 mmHg to about 250 mmHg, about 200 mmHg to about 300 mmHg, or about 250 mmHg to about 300 mmHg. In some embodiments, the photoactivated patch material withstands a hydrostatic pressure of about 120 mmHg, about 130 mmHg, about 140 mmHg, about 200 mmHg, about 250 mmHg, or about 300 mmHg. In some embodiments, the light-activated patch material withstands a hydrostatic pressure of at least about 120 mmHg, about 130 mmHg, about 140 mmHg, about 200 mmHg, or about 250 mmHg.

[0024] In some embodiments, the patch material is fully or partially activated while within a portion of the device. This pre-activation may occur within the bore of a needle, within the housing of the device, within the lumen of a catheter, within the patch cartridge, within the needle cartridge, within the handle of a ligation device, some other location prior to initiation at the wound site, or any combination thereof.

[0025] In some embodiments, the patch materials are specifically formulated, delivered, and cured to be capable of sealing tissue and material compromised by the biopsy procedure to prevent significant bleeding from compromised vessels or structures with internal hydrostatic pressures equal to or greater than arterial blood pressure (120 mmHg). In some embodiments, these patch materials are specifically formulated, delivered, and cured to be capable of sealing compromised vessels, tissues, fluids, turbulent fluid movement, bleeding, vascular malformation structures with intraluminal pressures, constant forces, pulsatile forces, hydrostatic pressures, or some combination thereof, equal to or greater than elevated human blood pressure (e.g., 140, 150, 160, ... 300 mmHg).

[0026] In some embodiments, the device delivers and / or cures the patch material through a needle or small lumen component having a lumen size equal to or smaller than the inner diameter of a 16 gauge needle (1.194 mm). In some embodiments, the device can modify tissue or material at or near the target site to improve delivery and / or closure of the relevant properties of the patch material (e.g., cauterizing tissue in preparation for attachment to the patch material).

[0027] In some embodiments, the patch material delivered and activated by the device is one or more types of photopolymerized patch material. In some embodiments, the photopolymerized patch material is used to close a certain portion or entire area associated with the associated treatment instrumentation, such as degenerated or damaged tissue, body duct, vessel, luminal containment, nerve, organ, capsule, structure, anatomical abnormality, and other biological material, or any combination thereof. The delivery and activation of these photopolymerized patch materials may be adjacent in time or separated in time, and may be selected from semi-automated, automated, or combinations thereof. In some embodiments, the properties of the photopolymerized patch material are modified or activated before, during, or after the normal operation of the treatment, such as immediately after cutting a biopsy specimen from a tissue layer. The delivery of the photoactivated patch material may be coupled with tissue modification by ultrasonic vibration cauterization, RF electrosurgery (monopolar or bipolar), resistive cauterization, other cauterization methods, freezing, or combinations thereof.

[0028] In some embodiments, the photoactive patch material is delivered to a specific target location during the treatment without the user's treatment process being significantly altered. In some embodiments, the components are mixed at or near the distal opening from which the components are released, thereby moving the components through the device at a reduced viscosity compared to the viscosity after mixing. In some embodiments, the material is heated or cooled to reduce its viscosity. In some embodiments, the patch material includes one or more photoinitiators, monomers, dimers, oligomers, polymers, synthetic materials, natural materials, semi-synthetic materials, solutes, solvents, nanoparticles, additives, other materials, or combinations thereof.

[0029] In some embodiments, the photoinitiator used to activate or assist in activating the patch material is one or more of LET (lithium phenyl-2,4,6-trimethylbenzoylphosphinate), Irgacure diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, ruthenium (Ru) metal complexes, bipyridine, ruthenium (Ru) metal complexes, Eosin Y, TEA, 1-vinyl-pyrrolidinone, triethanolamine (TEA, co-initiator), N-vinylcaprolactam (co-initiator), Omnicure, 2,2-azobis[2-methyl-(2-hydroxyethyl)propionamide] (VA-086), or combinations thereof.

[0030] In some embodiments, the viscosity or rheology values ​​required for the photopolymerized patch material are capable of stasis or preventing bleeding from arteries, other blood vessels, luminal contents, tissues, or materials at arterial levels of hydrostatic pressure, requiring significantly higher viscosity, toughness, and rheology values ​​than those previously described. In some embodiments, the viscosity of the biocompatible patch material upon delivery to the body site is from about 15 centipoise (cp) to about 100,000 cp.In some embodiments, the viscosity of the biocompatible patch material upon delivery to a biological site is from about 15 cp to about 50 cp, from about 15 cp to about 100 cp, from about 15 cp to about 500 cp, from about 15 cp to about 1,000 cp, from about 15 cp to about 3,000 cp, from about 15 cp to about 5,000 cp, from about 15 cp to about 10,000 cp, from about 15 cp to about 20,000 cp, from about 15 cp to about 100,000 cp, from about 50 cp to about 100 cp, from about 50 cp to about 500 cp, or from about 50 cp to about 50 cp. p ~ approx. 1,000 cp, approx. 50 cp ~ approx. 3,000 cp, approx. 50 cp ~ approx. 5,000 cp, approx. 50 cp ~ approx. 10,000 cp, approx. 0cp, about 100cp to about 1,000cp, about 100cp to about 3,000cp, about 100cp to about 5,000cp, about 100cp to about 10,000cp, about 100cp to about 20,000cp, about 100cp to about 100,00 0cp, about 500cp to about 1,000cp, about 500cp to about 3,000cp, about 500cp to about 5,000cp, about 500cp to about 10,000cp, about 500cp to about 20,000cp, about 500cp to about 100,00 0cp, about 1,000cp to about 3,000cp, about 1,000cp to about 5,000cp, about 1,000cp to about 10,000cp, about 1,000cp to about 20,000cp, about 1,000cp to about 100,000cp, about 3 ,000 cp to about 5,000 cp, about 3,000 cp to about 10,000 cp, about 3,000 cp to about 20,000 cp, about 3,000 cp to about 100,000 cp, about 5,000 cp to about 10,000 cp, about 5,000 cp to about 20,000 cp, about 5,000 cp to about 100,000 cp, about 10,000 cp to about 20,000 cp, about 10,000 cp to about 100,000 cp, or about 20,000 cp to about 100,000 cp. In some embodiments, the viscosity of the biocompatible patch material when it is delivered through the device is about 1 cp to about 10,000 cp.In some embodiments, the viscosity of the biocompatible patch material as it is delivered through the device is from about 1 cp to about 5 cp, from about 1 cp to about 10 cp, from about 1 cp to about 20 cp, from about 1 cp to about 50 cp, from about 1 cp to about 100 cp, from about 1 cp to about 500 cp, from about 1 cp to about 1,000 cp, from about 1 cp to about 5,000 cp, from about 1 cp to about 10,000 cp, from about 5 cp to about 10 cp p, about 5 cp to about 20 cp, about 5 cp to about 50 cp, about 5 cp to about 100 cp, about 5 cp to about 500 cp, about 5 cp to about 1,000 cp, about 5 cp to about 5,000 cp, about 5 cp to about 10,0 00cp, approximately 10cp to approximately 20cp, approximately 10cp to approximately 50cp, approximately 10cp to approximately 100cp, approximately 10cp to approximately 500cp, approximately 10cp to approximately 1,000cp, approximately 10cp to approximately 5,000cp, approximately 10cp to about 10,000cp, about 20cp to about 50cp, about 20cp to about 100cp, about 20cp to about 500cp, about 20cp to about 1,000cp, about 20cp to about 5,000cp, about 20 cp~about 10,000cp, about 50cp~about 100cp, about 50cp~about 500cp, about 50cp~about 1,000cp, about 50cp~about 5,000cp, about 50cp~about 10,000cp, about 100 cp to about 500 cp, about 100 cp to about 1,000 cp, about 100 cp to about 5,000 cp, about 100 cp to about 10,000 cp, about 500 cp to about 1,000 cp, about 500 cp to about 5,000 cp, about 500 cp to about 10,000 cp, about 1,000 cp to about 5,000 cp, about 1,000 cp to about 10,000 cp, or about 5,000 cp to about 10,000 cp.

[0031] In some embodiments, the photopolymerized patch material is selectively, partially, mostly, or completely activated by photons while the patch material is still within a portion of the device, thereby "toughening" the material prior to exposure to high pressure bleeding or tissue. An exemplary method of activation while within a portion of the device is illustrated in Figures 43A-43E. This may facilitate rapid closure of tissues bleeding heavily, closure of tissues bleeding at high or arterial pressure, closure of tissues with a dysfunctional or impaired coagulation system, adhesion to wet tissues or substances, prevention of dilution of the patch material, reduction in swelling ratio (SR) of the patch material, increase in viscoelastic strength of the patch material, increase in viscosity of the patch material, increase in contact area of ​​monomers and polymers to tissue, prevention of localized migration of the patch material, prevention or limitation of embolization of the patch material, reduction in curing time to grow a network or close tissue, reduction in time required to place needles or the device in or expose to an organ or tissue, or some combination thereof.

[0032] In some embodiments, the mesh or structure is formed by photopolymerization. In some embodiments, the microstructure is formed during initial polymerization. In some embodiments, the patch material includes one, two, or more different types of molecules to generate homogeneous, heterogeneous, or mixed polymer structures. These molecules may include, but are not limited to, one or more proteins, lipids, sugars, amino acids, polysaccharides, glycosaminoglycans, sugars, alcohols, synthetic molecules, natural molecules, partially synthetic molecules, bioadhesive type molecules, extracellular matrix type molecules, clotting molecules, plant-based molecules, bacterial-derived, animal-derived, or composite molecules, other types of molecules, or some combination thereof.

[0033] In some embodiments, the monomer contains chemically active molecules attached via chemical bonds, mechanical bonds, or a combination thereof to increase the number of potential activation sites. In some embodiments, the added molecules are acrylic groups, tyrosine groups, some other groups, or some combination of these or related molecules. In some embodiments, the patch material has a high concentration of these molecules present to increase the cure rate or increase the mechanical strength or adhesiveness of the patch material.

[0034] In some embodiments, the patch material may be a "dual network" type photopolymerization mixture in some embodiments. It may include one or more different types of monomers, dimers, polymers, or any combination thereof that are used to generate the 3D structure of the patch material upon curing. These molecules may include similar or different types of mechanical binding activity, chemical reactivity, binding activity, cure speed, degradation time, hydrophobicity, charge, shape, strength, elasticity, viscosity, viscoelasticity, burst pressure, fracture force, adhesion, shear strength, porosity, or uniformity.

[0035] A. Rapidly Polymerizing, Highly Adherent Biodegradable Hypertensive Arteriostatic Patch Material In some embodiments, the device includes a dual-network (or multi-network) patch material optimized for use in biopsies. In some embodiments, the patch material is a rapidly polymerizing, highly adherent, hypertensive arteriovenous biodegradable patch material. The patch material can exploit the benefits of each of its major components in different ways. This embodiment of the patch material typically includes one or more low molecular weight biodegradable monomers that rapidly photopolymerize under activation conditions, one or more high molecular weight biodegradable monomers that include (or are modified to include) one or more hydrophobic regions, and one or more photoinitiators. This combination may be ideally suited for use in biopsies, particularly liver biopsies, kidney biopsies, pancreatic biopsies, and the like.

[0036] This unique combination leverages the rapid polymerization of the small monomers to rapidly strengthen the patch material, reducing flow disturbances associated with arterial hemorrhage and accelerating interlocking between the inner 3-polymer structure and those at the tissue surface. The large monomers act as anchors to the tissue, leveraging their large size to entangle with surface molecules and strongly bind to the surface via hydrophobic interactions.

[0037] In some embodiments, the patch material mixture polymerizes rapidly despite arterial blood pressure and prevents secondary damage from the biopsy needle during the polymerization process. In some embodiments, the patch material features prevent excessive bleeding with any biopsy. In some embodiments, the concentrations of the patch material components are combined before or during the treatment process, whereby the rapidly polymerizing, highly adherent biodegradable patch material, when activated, is nearly completely cured within 0.5 seconds, 1 second, 1.5 seconds, 2 seconds, 2.5 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, or any other time considered rapid up to about 5 minutes, while also having a high adhesion force equal to or greater than that of the hydrostatic pressure of hypertensive arterial pressure, including 120 mmHG, 130 mmHG, 140 mmHG, 150 mmHG, 160 mmHG, 170 mmHG, up to about 300 mmHG, or more. In some embodiments, the patch material typically contains at least one bond that is cleavable in situ, thereby making it biodegradable within a few months, but requires more than five days to completely degrade in situ.

[0038] In some embodiments, examples of low molecular weight rapidly polymerizing biodegradable monomers in the rapidly polymerizing, highly adhesive hypertensive arteriovenous patch material include, but are not limited to, gelatin, gelma, polyethylene glycol, PEGMA, PEGDA, oxidized alginate, oxidized alginate methylacrylate, tropoelastin, tropoelastin-methyl acrylate, among others. This component may alternatively be present in the inactivated patch material in the form of a dimer, trimer, or small polymer. This component may have one or more methyl acrylate groups added to accelerate the reaction. This monomer, at the appropriate concentration, will fully polymerize when exposed to an appropriate light source for less than one or more of 0.5 seconds, 1 second, 1.5 seconds, 2 seconds, 2.5 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, or other considered times.

[0039] In some embodiments, the high molecular weight monomeric components of the rapidly polymerizing, highly adhesive biodegradable photopolymerized patch material are one or more of the following molecules: glycosaminoglycans, e.g., hyaluronic acid, collagen, chitosan, polyallylamine, proteins, e.g., fibrinogen, laminin, any other monomers larger than the smaller monomeric components, or any combination thereof. In some embodiments, the larger species has hydrophobic segments, including, but not limited to, one or more bioinspired phenolic groups, any other phenolic groups, any other hydrocarbon chains, hydrocarbon rings, fatty acids, glycerol, lipids, peptide segments with hydrophobic amino acid sequences significantly exposed to the outside world, any other externally accessible hydrophobic segments, or any combination thereof. The hydrophobic portion may be an inherent part of the larger molecule, a modification of another molecule, added before or during the patch formation process, or some combination thereof.

[0040] The rapidly polymerizing, highly adherent biodegradable hypertensive arteriovenous patch material may include one or more photoinitiator molecules such as those listed above. For additional benefits, the patch material may include one or more other additional molecules as described herein.

[0041] In some embodiments, the patch material is divided into component parts of a patch material cartridge, an instrument cartridge, a needle cartridge, a syringe, a dispenser, a capsule, or some combination thereof. Alternatively, it may be manually drawn up or injected before, during, or after treatment, such as by connecting a syringe to an introduction needle or some other port. The components of the rapidly polymerizing, highly adherent, hypertensive arteriovenous biodegradable patch material may be present as liquids, solids, semi-solids, dehydrated components, mixtures, or some combination thereof. Also, in some embodiments, additional cells, growth factors, antimicrobial agents, other components, or combinations thereof may be part of these mixtures.

[0042] In some embodiments, these fast polymerizing, highly adherent patch, hypertensive arteriovenous patch materials undergo an amount of initial exposure and activation within certain portions of the device, as described above. This pre-activation may occur within the patch cartridge, needle cartridge, needle bore, catheter lumen, or some combination thereof. In this type of mixture, the small monomers may be activated to allow stabilization of the 3D matrix, partial polymerization of the small monomers to the larger monomers, and long tissue anchors may be generated before extrusion into the wound site. This may also allow for non-covalent interactions, resulting in an increase in practical propagation resistance for the patch material. This may also provide more stability to the patch material matrix, allowing for closer interactions, more entanglement, and more covalent and more non-covalent bonds to form between the large monomers and the tissue once extruded.

[0043] In some embodiments, these rapidly polymerizing, highly adherent patch, hypertensive arteriovenous patch materials may include some other combination of ingredients, solutions, additives, mixtures, enhancers, or the like. In some embodiments, the concentration of the patch mixture of single monomers or monomers may provide the following characteristics: 1. Capable of being injected before, after, during, or in between biopsy procedures. 2. Possess adhesive properties such that they can rapidly stop and prevent heavy bleeding from hypertensive hydrostatic bleeding. 3. Biodegradable in about 5 days or more to about 1 year or less.

[0044] Specific examples that would benefit from these rapidly polymerizing, highly adherent biodegradable hypertensive arterial and venous patch materials include use in conjunction with renal and liver biopsies of all kinds, especially in advanced disease with significant bleeding.

[0045] In some embodiments, this rapidly polymerizing, highly adherent biodegradable hypertensive arteriovenous patch material is utilized in combination with the use of tissue modification (e.g., RF monopolar, RF bipolar, or HF ultrasonic ablation). The use of a rapidly polymerizing, highly adherent hypertensive arteriovenous patch (or similar mixture) in conjunction with tissue modification can reduce the radial thickness of the ablation required, increase adhesion, increase the rate of polymerization of the patch material, reduce protective gel on the surface of the tissue or biopsy site by drying of HO from native glycosaminoglycans (GAGs) and extracellular matrix (ECM) to better entangle with modified proteins and large monomer anchors, reduce the amount of patch material required, reduce washout, improve tissue to polymer self-repair, improve wound repair rate, and significantly reduce the risk of delayed bleeding.

[0046] In some embodiments, the device includes a luminal body ligation clamp. In some embodiments, a combination of RF bipolar, impedance sensing / directed ablation is utilized in combination with components, mechanisms, and controls for dispensing and activating a rapidly polymerizing material. This combination may be used for other types of needle-based procedures, such as closure of arterial wounds after cardiac catheterization, treatment of chronic wounds, closure of surgical wounds such as ear, nose and throat (ENT) surgery, and closure of chronic fistulas.

[0047] Certain dual network patch materials may contain a moderately concentrated combination of a rapidly polymerizing molecule (such as GelMA) and a second monomer that contains a "bioadhesive-inspired" polyphenol chain. When the highly hydrophobic bioadhesive polyphenol is released from the device near the measurement site, it rapidly binds to the tissue wall before fully polymerizing with other molecules. This rapid hydrophobic attachment can act as a simple temporary sealant, slowing bleeding enough for platelets to attach and form a 3D network with GelMA and attach to the polyphenol moiety.

[0048] In some embodiments, a particular patch material cartridge (or other form) is selected by the user prior to treatment with the device. In some embodiments, the patch material is specific to platelet dysfunction or other treatments where this risk factor is present. In some embodiments, the patch material is used, including concentrated oxidized alginic acid and hyaluronic acid. Oxidized alginic acid may be utilized, which degrades slower than most other types of components of the patch material, but can still harden quickly. In some embodiments, hyaluronic acid can provide a combination of rapid hardening, strengthening, and slow absorption, further strengthening the structure against blood pressure rise bleeding above 120mmHG, 160mmHG, 180mmHG, 200mmHG, or more.

[0049] In some embodiments, the patch material is configured to withstand extremely high pressure bleeding, particularly with high adhesion and high toughness. Patients with advanced renal disease have extremely high blood pressure (often over 220 mmHG) as well as coagulation deficiencies. In some embodiments, these biopsy patch materials consist of a concentrated mixture of GelMa and hyaluronic acid modifications, where the hyaluronic acid has been chemically modified to add hydrophobic moieties to the molecule, such as NB (N-(2-aminoethyl)-4-(4-(hydroxymethyl)-2-methoxy-5-nitrosophenoxy)butanamide). This creates a rapid (less than about 5 seconds) closure with high adhesion strength, burst pressure, or both.

[0050] In some embodiments, the patch materials do not require light activation to polymerize or seal the tissue. In some embodiments, these patch materials can still be delivered and / or activated to all or a portion of the tissue, structure, or material at the site of denaturation during instrumentation with the device. These patch materials may be governed by chemical, thermal, hydrophilic, ionic, pH, or any other mechanism of activation, occlusion, closure, or coagulation methods that do not require light activation to achieve the desired effect but can still be used to consistently prevent bleeding due to arterial pressure. These patch materials may consist of one or more of the following substances: Vitagel, avista, TraumaStat, ChitoSam, HemCon, Axiostar, Celox, thrombin, tranexamic acid, Floseal, Surgifoam, Gelfoam, Cyclopapron, quick clot, Erfa Tranexamic acid, other ingredients, or combinations thereof.

[0051] In other embodiments, chemicals or substances are provided to the patch material to reduce the viscosity of the fluid so that the fluid can flow through the smaller lumen more easily. In some embodiments, the facilitator can be reduced using a combination of internal and external activation at the distal end of the device and near the target site. In some embodiments, ingredients are used to selectively heat, cool, vibrate, denature, or otherwise modify the patch material to reduce viscosity, toughness, and / or adhesion to facilitate delivery through the needle. In some embodiments, the patch material may be delivered in a packet, capsule, pill, mesh, or other surrounding material or substance that can be removed, destroyed, crushed, or released near or at the target occlusion site.

[0052] Mixing the patch material may include mixing with substances at different times or at different locations within or on the device to adjust cure time, hi some embodiments, mixing includes mixing with substances at different times or at different locations within or on the device to adjust cure time, viscosity, pressure on surrounding tissue, elasticity, strength (compressive, shear, and / or tensile), sensing capabilities, or combinations thereof.

[0053] In some embodiments, the patch material includes tranexamic acid (TXA) liquid, solid, and / or gel (a plant-based product that promotes clotting). In some embodiments, the patch material includes PEGdma, PEGDA, PEGDA in combination with HA / GelMa / collagen, PEGDA in combination with biosensing PEGDA polyaniline, GelMa, GelMa with MeHA / heparin / gellan gum, GelMa with nanosilicate / hydroxyapatite, GelMa with graphene oxide and carbon nanotubes, GelMa with methacryloyl substituted tropoelastin, GelMa with dopamine, GelMa with polyacrylamide and chitosan nanoparticles, MeHA, methacrylate chondroitin sulfate, non-biological cartilage microparticles, and / or MeHA with N-cadherin mimetic peptide, MeHA with puratrix peptide. In some embodiments, the polymerization reaction is triggered by radical reaction of the photoinitiator during laser irradiation, thereby allowing the polymerization to be monitored in real time. In some embodiments, the patch material comprises SR 499. In some embodiments, the polymerization reaction is triggered by radical reaction of the photoinitiator during laser irradiation, thereby allowing the polymerization to be monitored in real time.

[0054] In some embodiments, the patch material includes microspheres, gelatin-based products used alone or in combination with coagulation promoters, cellulosic hemostatic agents, fibrin, synthetic glues, adhesives, pledgets, nanoparticles, microparticles, zeolites, smectites, sponges, and combinations thereof. In some embodiments, polysaccharide-based hemostatic agents are utilized. Hemostatic agents may include N-acetyl-glucosamine-containing glycosaminoglycans purified from microalgae and diatoms, and microporous polysaccharide hemospheres made from potato starch. The patch material may also include systemically delivered agents that aid and / or promote hemostasis of the procedure, delivered locally at the site or remotely by IV, IM, IO. The light-activated patch material may consist of light-activated or inactivated polysaccharides, fibrin molecules, and fibrinogen molecules.

[0055] In some embodiments, a mesh-like material, an embolic material, a solid material, or a highly viscous or viscoelastic material is used in combination with the patch material. In some embodiments, the patch material is extruded from a coaxial needle so that multiple layers contain different materials with potentially different properties. In some embodiments, the patch material includes ECM. In some embodiments, the patch material includes various architectural forms and compositions in different tissues. In some embodiments, the patch material includes a complex 3D network mainly composed of collagen and elastic fibers, which also include proteoglycans, multi-adhesive proteins (e.g., fibronectin, laminin), and glycosaminoglycans (e.g., hyaluronan).

[0056] In some embodiments, the patch material is photoinitiated by laser-based stereolithography and digital light projection (DLP). In some embodiments, the step of photoinitiating the patch material includes visible light curing of poly(2-hydroxyethyl methacrylate) (p-HEMA) hydrogel under 405 nm light irradiation + / - sodium alginate.

[0057] In some embodiments, the patch material includes nanoparticles. The nanoparticles can be utilized to occlude and release other molecules. The rate, amount, and timing can be altered in various ways and may be caused by a specific stimulus. For example, the nanostructures, in some embodiments, can be stimulated to activate by a drop in pH to release an antimicrobial agent (antibiotic). The presence of bacteria can cause a local drop in pH, which in this example stimulates the nanoparticles to release a substance that will kill the bacteria. The nanoparticles may also release cells or cell stimulating molecules. Stimulating molecules may be utilized to release molecules to stimulate vascular and glomerular neogenesis when placed during a kidney biopsy. Stimulating molecules may also be placed with stem cells or other growth factors when closing the kidney tissue after the biopsy. The released substances also help differentiate the stem cells into certain cell lines or structures. The nanoparticles utilized may include silica nanoparticles, ceramic nanoparticles, carbon nanotubes, heat-sensitive nanoparticles, photon-sensitive nanoparticles, nanoparticles with other sensitivities to stimuli (e.g., pressure, cooling, heat, etc.), and combinations thereof.

[0058] In some embodiments, the light-activated binding material combination is mixed with, bound to, isolated from, or associated with a chemical that promotes blood clot formation, thereby resulting in a sealing chemical combination and a chemical that promotes blood clot formation. In some embodiments, the material combination prevents and / or reduces the amount of clotting occurring in other parts of the organ(s) remote from the instrumented portion, for example, preventing clotting or accumulation of material in renal tubules, the bile duct system, lymphatic system, and other blood vessels.

[0059] In some embodiments, the patch material is modified in some way to change the spectrum of wavelengths, thereby creating or breaking chemical bonds. For example, a material that normally creates bonds only when exposed to photons in the UV spectrum may be chemically modified to create bonds in the visible spectrum. These changes may be caused by one or more chemical, electrical, or mechanical reactions, or in some other way.

[0060] B. Repair structure In some embodiments, the patch material comprises a gel, a solidified cast, a liquid, a compartmented compartment, a tape, a mesh, a mixed gel, a capsule, a packet, a plug, a powder, a cream, or a combination thereof. In some embodiments, the patch material comprises one or more monomeric, dimeric, and / or polymeric components and a crosslinking agent. In some embodiments, the polymeric components and the crosslinking agent are combined and / or bonded before, during, and / or after the procedure. In some embodiments, the patch material comprises a polymeric material selected from the group consisting of gelatin, alginate, fibrin, silk fibers, ethylene glycol, polyethylene glycol, collagen (type I, type II, type IV, and / or modified), chitosan, hyaluronic acid, genipin and genipin scaffolds, nucleic acids, e.g., DNA, RNA, and modified forms, plant-derived molecules, cellulose, polymers of indocyanine green, polysaccharides, e.g., cellulose, dextran, agarose, biosentry hydrogels, Taracel, and the like. T-hydrogels, SpaceOAR hydrogels, fibrinogen, albumin, Evicel, Coseal, n-vinylamides and hydroxyls, hydroxyalkyl methacrylates, methylacrylamide, hydrogels with one, two or more ways to stimulate a response to a stimulus, Ventrigel, silica-based hydrogels, polymeric components within other substances, polyethylene oxide, bioadhesive hydrogels, oxidized pullulan, carboxyl-containing hydrogels, cellulose, cellulose-silica-based hydrogels, polymeric fiber bases that may or may not be bound to the hydrogel, polyalkylene glycols, antimicrobial hydrogels, lyophilized hyaluronic acid, hypromellose, nanofiber hydrogel hybrids, hydroxyethylcellulose, chitosan-grafted dihydrocaffeic acid, chitosan alginate, drug-loaded micelles, chitosan, polyacrylamide, and collagen containing hyaluronic acid, polyacrylonitrile, hydroxymethylcellulose, radiopaque materials, ABA triblock copolymers of vitamin D, functionalized polycarbonates, polymer-nanoparticles, chondroitin sulfate (chondroitin sulfate) sulfate), hylauronine, polyester polymers such as PLA, PCL, PGS, PU, ​​conductive polymers such as PPY, PTh,pani, bioactuators, biosensors, e.g., PLC-collagen nanofibers, metal and metal oxide nanoparticles, titanium dioxide nanoparticles, graphene, graphene oxide-alginate, elastin, tropoelastin, Alg-MA (alginate-methacrylic acid), MeTro (methacrylamide pendant of tropoelastin) pendant), alginate, BD-mannuronic acid, α-L-guluronic acid, albumin, Evicel, Coseal, Tisseel, tyrosine-rich molecules, molecules modified to contain more tyrosine molecules, mussel adhesive proteins (MAPs) (natural, synthetic, recombinant, and modified), e.g., LAMBA, 3,4-dihydroxyphenylalanine (DOPA)-rich molecules, polyacrylamide, polyvinyl alcohol, hybrid molecules, chitin, chitosan, catechol, 3,4-dihydroxybenzaldehyde, benzyl azide, carbodiimide, heparin, gelatin gum, carbon nanotubes, other components of the extracellular matrix, which has various architectural forms and compositions in different tissues, mainly composed of collagen, elastic fibers, multi-adhesive proteins (e.g., fibronectin, laminin), proteoglycans, glycosaminoglycans (e.g., hyaluronan, Ronan), N-3-dimethylaminopropyl-N-ethylcarbodiimide hydrochloride (EDC), phenolated molecules, chondroitin sulfate (CS), CS-MA, oxCS-MA (oxidized with periodic acid), poly(2-hydroxyethyl methacrylate) (polyHEMA), dextran (polysaccharide), DexMA, OxDex-MA-Gel, DMSO, 2-isocyanatoethyl methacrylate, 2-nitrobenzyl alcohol, polyethyleneimine, E-poly(L-lysine), bovine serum albumin, PRP (platelet rich plasma), oNB-CMC, carboxymethylcellulose, N-aliphatic diethanolamide (soybean diol), copolyesters, 2,2-dimethoxy-2-phenylacetate phenan, calcium lactate-containing alginate, tyrosine kinase inhibitors, vitamin E-containing copolymers, glutathione crosslinkers, thiols. In some embodiments, the patch material comprises:These include elastic composite hydrogels based on methacryloyl elastin-like polypeptide (mELP) in combination with gelatin methacryloyl (GelMA) and firm glues based on pure GelMA. The use of multiple gels, such as elastic composite hydrogels based on methacryloyl elastin-like polypeptide (mELP) in combination with gelatin methacryloyl (GelMA) and firm glues based on pure GelMA, may allow benefits from different properties. Two formulations with different mechanical properties may be required to achieve a stable anastomosis.

[0061] In some embodiments, the patch material is GelMA, GelMA-MeHA / heparin / gelitan gum, GelMA-nanosilcate / hydroxyapatite, GelMA-graphene oxide / carbon nanotubes, GelMA-methylacryloyl substituted tropoelastin, GelMA-dopamine, GelMA-polyacrylamide / chitosan nanoparticles, GelMA-nickel nanoparticles + reduced graphene oxide, Gel-St (gelatin functionalized with styrene groups), GelDA, PEGDA (polyethylene glycol diacrylate), PEGDA-HA / GelMA / collagen, MeHA, MeHA These include Puramatrix peptides, MeHA-methyl chondroitin sulfate acrylate / n-cadherin mimetic peptide, PegMA, PegMA-polyaniline, Gel-X (xanthene-linked gelatin), benzophenone-linked gelatin (Gel-BPh), oxidized variants of molecules that improve their adhesive properties (especially under wet conditions), sodium periodate (sometimes used during oxidation), IDCG-chitosan, gelatin with pendant catechol groups (Gel-Cat), phloretic acid, gelatin with pendant phenol (Gel-Phe), methacrylic anhydride, 2-hydroxy-4'-(2-hydroxyethoxy)-2-methylpropiophenone (Igacure 2959), PEG-dimethylacrylate, thiol pendant chiotosen, glycol chitosan (G-CH), AZ-CH-LA, CH-MA-Cat, ethylene glycol, catechol-added 3-arm PEG, or combinations thereof.

[0062] In some embodiments, the patch material comprises natural polymer hydrogels and / or synthetic polymer hydrogels. Synthetic hydrogels may include poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), polyethylene glycol) (PEG), poly(ε-caprolactone) (PCL), poly(2-hydroxyethyl methacrylate) (p-HEMA). In some embodiments, the patch material comprises a photocuring biopsy hemostat, a photoocclusive biopsy hemostat, an epoxy-based material, SU8, CAR44, an acrylate-based material, ormocer, or a combination thereof. In some embodiments, the patch material comprises an inorganic / organic hybrid polymer. In some embodiments, the patch material is synthesized by a sol-gel process, whereby inorganic units are bonded to organic moieties at the molecular level. In certain embodiments, the polymer is a hybrid. In some embodiments, the hybrid material combines the properties of organic polymers (low temperature processing, functionality, and toughness) with the properties of glass-like materials (hardness, chemical and thermal stability, and transparency). This may make it possible to achieve material properties that are inaccessible with composite or polymeric materials.

[0063] II. Morphological Factors A. Needle In some embodiments, the needle comprises a Chiba needle, a Turner needle, a Madayag needle, a spinal needle, a Greene needle, a Franseen needle, a Wescott needle, a side-cutting Tru-Cut biopsy needle, a rotary needle, a center-cutting biopsy needle, a full-core biopsy needle, a lancet-tip biopsy needle, a biopsy needle or system utilizing a vacuum component, a fine needle aspiration needle, or a combination of features thereof. 1. Sheath In some embodiments, the device includes a sheath. In some embodiments, the sheath contains a specimen tray. In some embodiments, the sheath is configured as a cutting sheath. In some embodiments, the sheath closes one or more openings that release the patch material. In some embodiments, the sheath covers a reservoir that contains the patch material. In some embodiments, there is a stable sheath that is fixedly connected at its proximal end to one or more portions of the device. At its distal end, it terminates a short distance from the distal end of the needle, approximately 5 cm from the tip of the needle, which may vary from about 2 cm to about 10 cm from the tip. In some embodiments, the sheath stabilizes the device and provides an anchor point, so that the patch of the inner or outer biopsy needle, catheter, light delivery component, or any other part of the device can be smoothly retracted from a distal location to a proximal location toward the body of the device without the handle being pulled toward the inside of the patient. This also helps ensure accurate curing times, an important aspect for curing the patch material to have the high adhesion and toughness required to hemostatically stop and close hypertensive arterial bleeding.

[0064] 2. Needle and sheath movement In some embodiments, the device comprises an actuator for controlling advancement and / or retraction of the needle. In some embodiments, the actuator is a piezoelectric actuator. In some embodiments, the movement of the sheath is automated. In some embodiments, the movement of the needle is automated. In some embodiments, the automated movement of the sheath controls the speed and distance of movement. In some embodiments, the automated movement of the needle controls the speed and distance of movement.

[0065] In some embodiments, as shown in Figures 5A-5D, the sheath includes one or more sections that rotate to excise the tissue sample and contain the tissue sample in the sample tray (530). The rotating sections may be referred to as wings. In some embodiments, the ends of the wings are provided with sharp cutting surfaces (505).

[0066] 3.Introducing needle In some embodiments, an introducer needle is utilized. The introducer needle may first be inserted proximal to the biopsy target site. A biopsy needle may then be introduced through the introducer needle. The biopsy needle may then be utilized to perform a biopsy and contain a tissue sample within the trough of the biopsy needle. After the biopsy is performed, a repair needle may be guided through the introducer needle and placed at the biopsy site. Once the repair needle reaches the biopsy site, it may inject a biocompatible patch material at the biopsy site. In some embodiments, the repair needle comprises a light emitting surface formed by a waveguide that guides a light source to the distal end of the needle. The light source may be activated to initiate photopolymerization of the biocompatible patch material at the biopsy site.

[0067] B.Light source In some embodiments, the photons are used to control some portion of the device, hi some embodiments, the emission of photons is timed to insert or retract a needle, to timing the release of a photoactivated substance, to control the amount of photoactivated substance released, to control the shape of the 3D printed object, or a combination thereof.

[0068] In some embodiments, the device comprises a light curing component including one, two, or more light generating sources, light transmissive components, waveguides, connectors, couplers, filters, projectiles, diffusers, optical fibers, optical sensors, thermal sensors, position sensors, light emitters, optical fibers, fiber cores, gratings, filters, shutters, fiber claddings, waveguide claddings, components with attached or embedded optical components, catheters, wires, cables, connectors, waveguides, photon sensing components, computing devices, controllers, accessories for controlling the movement of some of these components, components for causing the movement of these components, components for coupling the movement of these components to the movement of other components, automatic controls, manual controls, semi-automatic controls, needles, patch materials, or other light delivery related components, or any combination thereof.

[0069] In some embodiments, the device comprises one or more photon generating sources located in one or more of the following locations: within the device housing, outside the device housing, within a remote control unit, outside the remote control unit, within the device handle, outside the handle, a removable internal module, a permanent internal module, a removable external module, a permanent external module, within the lumen of the inner needle, within the lumen of the outer needle, within the lumen of the advanced catheter, within the lumen of the fixed catheter, within the body of the needle, within the body of the catheter, some other location, or a combination thereof. In some embodiments, the light source is permanently attached, temporarily attached, reusable, disposable, autoclavable, rechargeable, partially disposable, partially reusable, cleaned with a disinfectant, covered with a drape, covered with a sterile sleeve, covered with a sterile capsule, otherwise modified, or a combination thereof.

[0070] In some embodiments, the light source may include an electrochemical light source, a gaseous light source (e.g., a gas laser), a chemical source, a laser source, an LED (light emitting diode), a solar light source, a mechanical power source, a tungsten lamp, a tungsten halogen lamp, a high pressure gas discharge lamp, an arc lamp (e.g., a xenon or mercury xenon high pressure lamp), a low pressure discharge lamp, a special fluorescent fluorescent lamp (e.g., a UV fluorescent lamp), other continuous sources (e.g., LEDs and synchrotrons), a pulsed source (e.g., a flash lamp), two-photon polymerization with ultrashort laser pulses (e.g., as used in nanoscale 3D printing), or combinations thereof. In some embodiments, the device includes protective light filtering components such as filters, gratings, shudders, shades, other components, or combinations thereof to limit exposure of biological tissue to dangerous frequencies.

[0071] The laser light or beam light may be emitted by a laser. The laser light may be emitted by a continuous wave laser. The laser light may be emitted by a pulsed laser. The laser light may be emitted by a gas laser, such as a helium neon (HeNe) laser, an argon (Ar) laser, a krypton (Kr) laser, a xenon (Xe) ion laser, a nitrogen (N2) laser, a carbon dioxide (CO2) laser, a carbon monoxide (CO) laser, a transversely excited atmospheric (TEA) laser, or an excimer laser. For example, the laser light may be emitted by an argon dimer (Ar2) excimer laser, a krypton dimer (Kr2) excimer laser, a fluorine dimer (F2) excimer laser, a xenon dimer (Xe2) excimer laser, an argon fluoride (ArF) excimer laser, a krypton chloride (KrCl) excimer laser, a krypton fluoride (KrF) excimer laser, a xenon bromide (XeBr) excimer laser, a xenon chloride (XeCl) excimer laser, or a xenon fluoride (XeF) excimer laser. The laser light may be emitted by a dye laser.

[0072] The laser light may be emitted by a metal vapor laser, such as a helium cadmium (HeCd) metal vapor laser, a helium mercury (HeHg) metal vapor laser, a helium selenium (HeSe) metal vapor laser, a helium silver (HeAg) metal vapor laser, a strontium (Sr) metal vapor laser, a neon copper (NeCu) metal vapor laser, a copper (Cu) metal vapor laser, a gold (Au) metal vapor laser, a manganese (Mn) metal vapor laser, or a manganese chloride (MnCl2) metal vapor laser.

[0073] The laser light may be emitted by a solid-state laser, such as a ruby ​​laser, a metal-doped crystal laser, or a metal-doped fiber laser. For example, the light source may be a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser, a neodymium / chromium-doped yttrium aluminum garnet (Nd / Cr:YAG) laser, an erbium-doped yttrium aluminum garnet (Er:YAG) laser, a neodymium-doped yttrium lithium fluoride (Nd:YLF) laser, a neodymium-doped yttrium orthovanadate (ND:YVO4) laser, a neodymium-doped yttrium calcium oxoborate (Nd:YCOB) laser, a neodymium-glass (Nd:glass) laser, a titanium sapphire (Ti:sapphire) laser, a thulium-doped yttrium aluminum garnet (Tm:YAG) laser, an ytterbium-doped yttrium The laser may be emitted by a ytterbium aluminum garnet (Yb:YAG) laser, an ytterbium doped glass (Yt:glass) laser, a holmium yttrium aluminum garnet (Ho:YAG) laser, a chromium doped zinc selenide (Cr:ZnSe) laser, a cerium doped lithium strontium aluminum fluoride (Ce:LiSAF) laser, a cerium doped lithium calcium aluminum fluoride (Ce:LiCAF) laser, an erbium doped glass (Er:glass) laser, an erbium ytterbium co-doped glass (Er / Yt:glass) laser, a uran doped calcium fluoride (U:CaF2) laser, or a samarium doped calcium fluoride (Sm:CaF2) laser.

[0074] The laser light may be emitted by a semiconductor laser or diode laser, such as a gallium nitride (GaN) laser, an indium gallium nitride (InGaN) laser, an aluminum gallium indium phosphide (AlGaInP) laser, an aluminum gallium arsenide (AlGaAs) laser, an indium gallium arsenide phosphide (InGaAsP) laser, a vertical cavity surface emitting laser (VCSEL), or a quantum cascade laser.

[0075] The laser light may be a continuous wave laser light. The laser light may be a pulsed laser light. The laser light may be a pulsed laser light. The laser light may be a pulsed laser light. The laser light may be a pulsed laser light. The laser light may be a pulsed laser light. , at least 400 fs, at least 500 fs, at least 600 fs, at least 700 fs, at least 800 fs, at least 900 fs, at least 1 picosecond (ps), at least 2 ps, at least 3 ps, at least 4 ps, at least 5 ps, at least 6 ps, at least 7 ps, at least 8 ps, at least 9 ps, at least 10 ps, ​​at least 20 ps, ​​at least 30 ps, ​​at least 40 ps, ​​at least 50 ps, ​​at least 60 ps, ​​at least The laser light may have a pulse length of at least 70 ps, ​​at least 80 ps, ​​at least 90 ps, ​​at least 100 ps, ​​at least 200 ps, ​​at least 300 ps, ​​at least 400 ps, ​​at least 500 ps, ​​at least 600 ps, ​​at least 700 ps, ​​at least 800 ps, ​​at least 900 ps, ​​at least 1 nanosecond (ns), at least 2 ns, at least 3 ns, at least 4 ns, at least 5 ns, at least 6 ns, at least 7 ns, at least 8 ns, at least 9 ns, at least 10 ns, at least 20 ns, at least 30 ns, at least 40 ns, at least 50 ns, at least 60 ns, at least 70 ns, at least 80 ns, at least 90 ns, at least 100 ns, at least 200 ns, at least 300 ns, at least 400 ns, at least 500 ns, at least 600 ns, at least 700 ns, at least 800 ns, at least 900 ns, at least 1,000 ns, or more. The laser light may have a pulse length within a range defined by any two of the foregoing values. For example, the laser light may have a pulse length between 1 ns and 50 ns.

[0076] The laser light may have a frequency of at least 1 Hertz (Hz), at least 2 Hz, at least 3 Hz, at least 4 Hz, at least 5 Hz, at least 6 Hz, at least 7 Hz, at least 8 Hz, at least 9 Hz, at least 10 Hz, at least 20 Hz, at least 30 Hz, at least 40 Hz, at least 50 Hz, at least 60 Hz, at least 70 Hz, at least 80 Hz, at least 90 Hz, at least 100 Hz, at least 200 Hz, at least 300 Hz, at least 400 Hz, at least 500 Hz, at least 600 Hz, at least 700 Hz, at least 800 Hz, at least 900 Hz, at least 1 kilohertz (kHz), at least 2 kHz, at least 3 kHz, at least 4 kHz, at least 5 kHz, at least 6 kHz, at least 7 kHz, at least 8 kHz, at least 9 kHz, at least 10 kHz, at least 20 kHz, at least 30 kHz, at least 40 kHz, at least 50 kHz, at least 60 kHz, at least 70 kHz, at least 80 kHz, at least 90 kHz, at least 100 kHz, at least 200 kHz, at least 300 kHz, at least 400 kHz, at least 500 kHz, at least 600 kHz, at least 700 kHz, at least 800 kHz, at least 900 kHz, at least 1 megahertz (MHz), at least 2 MHz, at least 3 MHz, at least 4 MHz, at least 5 MHz, at least 6 MHz, at least 7 MHz, at least 8 MHz, at least 9 MHz, at least 10 MHz, at least 20 MHz, at least 30 MHz, at least 40 MHz, at least 50 MHz, at least 60 MHz, at least 70 MHz, at least 80 MHz, at least 90 MHz, at least 100 MHz, at least 200 MHz, at least 300 MHz, at least 400 MHz, at least 500 MHz, at least 600 MHz, at least 700 MHz, at least 800 MHz, at least 900 MHz, at least 1,000 MHz, or more. The laser light may have a repetition rate that is within a range defined by any two of the aforementioned values.

[0077] The laser light may be at least 1 nanojoule (nJ), at least 2 nJ, at least 3 nJ, at least 4 nJ, at least 5 nJ, at least 6 nJ, at least 7 nJ, at least 8 nJ, at least 9 nJ, at least 10 nJ, at least 20 nJ, at least 30 nJ, at least 40 nJ, at least 50 nJ, at least 60 nJ, at least 70 nJ, at least 80 nJ, at least 90 nJ, at least 100 nJ, at least 200 nJ, at least 300 nJ, at least 400nJ, at least 500nJ, at least 600nJ, at least 700nJ, at least 800nJ, at least 900nJ, at least 1 microjoule (μJ), at least 2 μJ, at least 3 μJ, at least 4 μJ, at least 5 μJ, at least 6 μJ, at least 7 μJ, at least 8 μJ, at least 9 μJ, at least 10 μJ, at least 20 μJ, at least 30 μJ, at least 40 μJ, at least 50 μJ, at least 60 μJ, at least 70 μJ, at least 80 μJ, at least 90 μJ, at least 100 μJ, at least 200 μJ, at least 300 μJ, at least 400 μJ, at least 500 μJ, at least 600 μJ, at least 700 μJ, at least 800 μJ, at least 900 μJ, at least 1 millijoule (mJ), at least 2 mJ, at least 3 mJ, at least 4 mJ, at least 5 mJ, at least 6 mJ, at least 7 mJ, at least 8 mJ, at least 9 mJ, at least 10 mJ, at least 20 mJ, at least 30 mJ, at least 40 mJ, at least 50 mJ, at least 60 mJ, at least 70 mJ, at least 80 mJ, at least 90 mJ, at least 100 mJ, at least 200 mJ, at least 300 mJ, at least 400 mJ, at least 500 mJ, at least 600 mJ, at least 700 mJ, at least 800 mJ, at least 900 mJ, at least 1 Joule (J), or more. The laser light may have a pulse energy that is within a range defined by any two of the aforementioned values. For example, the laser light may have a pulse energy between 100 mJ and 500 mJ.

[0078] The laser light may be at least 1 microwatt (μV), at least 2 μW, at least 3 μW, at least 4 μW, at least 5 μW, at least 6 μW, at least 7 μW, at least 8 μW, at least 9 μW, at least 10 μW, at least 20 μW, at least 30 μW, at least 40 μW, at least 50 μW, at least 60 μW, at least 70 μW, at least 80 μW, at least 90 μW, at least 100 μW, at least 200 μW, at least 300 μW, at least 400 μW, at least 500 μW, at least 600 μW, at least 700 μW, at least 800 μW, at least 900 μW, at least 1 milliwatt (mW), at least 2 mW, at least 3 mW, at least 4 mW, at least 5 mW, at least 6 mW, at least 7 mW, at least 8 mW, at least 9 mW, at least 10 mW, at least 20 mW, at least 30 mW, at least 40 mW, at least 50 mW In one embodiment, the optical fiber 100 may have an average power of at least 1 W, at least 60 mW, at least 70 mW, at least 80 mW, at least 90 mW, at least 100 mW, at least 200 mW, at least 300 mW, at least 400 mW, at least 500 mW, at least 600 mW, at least 700 mW, at least 800 mW, at least 900 mW, at least 1 Watt (W), at least 2 W, at least 3 W, at least 4 W, at least 5 W, at least 6 W, at least 7 W, at least 8 W, at least 9 W, at least 10 W, at least 20 W, at least 30 W, at least 40 W, at least 50 W, at least 60 W, at least 70 W, at least 80 W, at least 90 W, at least 100 W, at least 200 W, at least 300 W, at least 400 W, at least 500 W, at least 600 W, at least 700 W, at least 800 W, at least 900 W, at least 1,000 W, or more. The laser light may have a power that is within a range defined by any two of the aforementioned values.

[0079] The laser light may include wavelengths in the ultraviolet (UV), visible, or infrared (IR) portions of the electromagnetic spectrum. The laser light may have wavelengths of at least 100 nanometers (nm), at least 110 nm, at least 120 nm, at least 130 nm, at least 140 nm, at least 150 nm, at least 160 nm, at least 170 nm, at least 180 nm, at least 190 nm, at least 200 nm, at least 210 nm, at least 220 nm, at least 230 nm, at least 240 nm, at least 250 nm, at least 260 nm, at least 270 nm, at least 280 nm, at least 290 nm, at least 300 nm, at least 310 nm, at least 320 nm, at least 330 nm, at least 340 nm, at least 350 nm, at least 360 nm, at least 370 nm, at least 380 nm, at least 390 nm, at least 400 nm, at least 410 nm, at least 420 nm, at least 430 nm, at least 440 nm, at least 450 nm, at least 460 nm, at least 470 nm, at least 480 nm, at least 490 nm, at least 500 nm, at least 510 nm, at least 520 nm, at least 530 nm, at least 540 nm, at least 550 nm, at least 560 nm, at least 570 nm, at least 580 nm, at least 590 nm, at least 600 nm, at least 610 nm, at least 620 nm, at least 630 nm, at least 640 nm, at least 650 nm, at least 660 nm, at least 670 nm, at least 680 nm, at At least 300nm, at least 310nm, at least 320nm, at least 330nm, at least 340nm, at least 350nm, at least 360nm, at least 370nm, at least 380nm, at least 390nm, at least 400nm, at least 410nm, at least 420nm, at least 430nm, at least 440nm, at least 450nm, at least 460nm, at least 470nm, at least 480nm, at least 490nm, at least 500nm, at least 510nm m, at least 520 nm, at least 530 nm, at least 540 nm, at least 550 nm, at least 560 nm, at least 570 nm, at least 580 nm, at least 590 nm, at least 600 nm, at least 610 nm, at least 620 nm, at least 630 nm, at least 640 nm, at least 650 nm, at least 660 nm, at least 670 nm, at least 680 nm, at least 690 nm, at least 700 nm, at least 710 nm, at least 720 nm, at least Also 730nm, at least 740nm, at least 750nm, at least 760nm, at least 770nm, at least 780nm, at least 790nm, at least 800nm, at least 810nm, at least 820nm, at least 830nm, at least 840nm, at least 850nm, at least 860nm, at least 870nm, at least 880nm, at least 890nm, at least 900nm, at least 910nm, at least 920nm, at least 930nm, at least 940nm,At least 950 nm, at least 960 nm, at least 970 nm, at least 980 nm, at least 990 nm, at least 1,000 nm, at least 1,010 nm, at least 1,020 nm, at least 1,030 nm, at least 1,040 nm, at least 1,050 nm, at least 1,060 nm, at least 1,070 nm, at least 1,080 nm, at least 1,090 nm, at least 1,100 nm, at least 1,110 nm, at least 1,120 nm, at least 1,130 nm, at least 1,140 nm, at least 1,150 nm, at least 1,160 nm, at least 1,170 nm, at least 1,180 nm, The laser light may include wavelengths of at least 1,190 nm, at least 1,200 nm, at least 1,210 nm, at least 1,220 nm, at least 1,230 nm, at least 1,240 nm, at least 1,250 nm, at least 1,260 nm, at least 1,270 nm, at least 1,280 nm, at least 1,290 nm, at least 1,300 nm, at least 1,310 nm, at least 1,320 nm, at least 1,330 nm, at least 1,340 nm, at least 1,350 nm, at least 1,360 nm, at least 1,370 nm, at least 1,380 nm, at least 1,390 nm, at least 1,400 nm, or more. The laser light may include wavelengths within a range defined by any two of the preceding values.

[0080] The laser light may be at least 0.001 nm, at least 0.002 nm, at least 0.003 nm, at least 0.004 nm, at least 0.005 nm, at least 0.006 nm, at least 0.007 nm, at least 0.008 nm, at least 0.009 nm, at least 0.01 nm, at least 0.02 nm, at least 0.03 nm, at least 0.04 nm, at least 0.05 nm, at least 0.06 nm, at least 0.07 nm, at least 0.08 nm, at least 0.09 nm, at least 0.1 nm, at least 0.2 nm, at least 0.3 nm, The laser light may have a bandwidth of at least 0.4 nm, at least 0.5 nm, at least 0.6 nm, at least 0.7 nm, at least 0.8 nm, at least 0.9 nm, at least 1 nm, at least 2 nm, at least 3 nm, at least 4 nm, at least 5 nm, at least 6 nm, at least 7 nm, at least 8 nm, at least 9 nm, at least 10 nm, at least 20 nm, at least 30 nm, at least 40 nm, at least 50 nm, at least 60 nm, at least 70 nm, at least 80 nm, at least 90 nm, at least 100 nm, or more. The laser light may have a bandwidth that is within a range defined by any two of the foregoing values.

[0081] The laser light may have a diameter (e.g., Rayleigh beam width, full width at half maximum, 1 / e) of at least 0.1 mm, at least 0.2 mm, at least 0.3 mm, at least 0.4 mm, at least 0.5 mm, at least 0.6 mm, at least 0.7 mm, at least 0.8 mm, at least 0.9 mm, at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm, at least 9 mm, at least 10 mm, at least 20 mm, at least 30 mm, at least 40 mm, at least 50 mm, at least 60 mm, at least 70 mm, at least 80 mm, at least 90 mm, at least 100 mm, or more. 2The first light may have a diameter of up to 100 mm, up to 90 mm, up to 80 mm, up to 70 mm, up to 60 mm, up to 50 mm, up to 40 mm, up to 30 mm, up to 20 mm, up to 10 mm, up to 9 mm, up to 8 mm, up to 7 mm, up to 6 mm, up to 5 mm, up to 4 mm, up to 3 mm, up to 2 mm, up to 1 mm, up to 0.9 mm, up to 0.8 mm, up to 0.7 mm, up to 0.6 mm, up to 0.5 mm, up to 0.4 mm, up to 0.3 mm, up to 0.2 mm, up to 0.1 mm, or less.

[0082] In some embodiments, the device uses a specific laser photocoagulation system depending on the part of the body, the pathophysiological condition, etc. In some embodiments, the device is configured to perform photocoagulation at wavelengths specific for coagulating blood, ablating blood vessels, drying water, cauterizing, or any combination thereof. The waveguides in these embodiments use one or more waveguides capable of propagating this photocoagulation light.

[0083] In some embodiments, the device modifies the surface of the wound using photocoagulation and then applies a patching material, which in some embodiments is a highly adherent, rapidly curing photopolymerized hydrogel, in some embodiments, the device includes multiple light sources so that it can both photocoagulate and cure the photopolymerized gel.

[0084] In some embodiments, the device comprises a light source connected to a rapidly extendable power source. In some embodiments, the rapidly extendable power source may be a retractable circuit system in the handle, power cartridge, instrument cartridge, needle cartridge, or some other part of the device. In some embodiments, the device may have a rapidly extendable power source by electronic connection to the instrument cartridge through a component that also connects the driving force of one or more actuators to the instrument cartridge or needle cartridge. In some embodiments, the rapidly extendable portion of the device comprises a low mass portion that adds little weight to the component, translating motion through the drive system to perform the biopsy. In some embodiments, the rapidly extendable power system comprises a portion with a low friction coating that allows sliding translation while limiting the increase in the required force. In some embodiments, when using a reusable power source, the rapidly extendable portion of the device is incorporated into the reusable compartment. When using a high blood pressure gel, such gel is highly adhesive and can quickly impair any telescopic or extendable portion of the translation of the biopsy needle.

[0085] 1. Optimal heat or vibration resistance of transilluminating catheters for use in combo devices In some embodiments, one or more of the optically transmissive components of the catheter are made of one or more types of glass, plastic, silica material, non-silica material, polymer optical fiber, Fontex, synthetic material, natural material, hydrogel, elastomer, some other type of material, or combinations of these types of materials. In some embodiments, one or more of the optically transmissive components are made of one or more materials optimized for use in one or more specific types of procedures, biopsies, patch materials, surgery, endoscopy, bronchoscopy, wound treatment, organs, tissues, substances, disease states, sizes, shapes, widths, mechanical properties, flexibility, bending stiffness, elasticity, tensile strength, shear strength, fracture strength, melting point, flexibility, electrical conduction or resistance (or impedance), thermal conduction or resistance, vibration conduction or resistance, optical propagation properties, optical propagation loss, optical attenuation, optical frequency, optical biocompatibility, optical power, non-toxicity, degradation time, self-healing properties, wavelength, power, or some combination thereof.

[0086] In some embodiments, there are unexpected advantages to including one or more of the light-transducing materials with stretchable optical fibers. Some embodiments need to be lightweight for precise control, extended use (especially where there are patch cure times greater than 5-10 seconds), or other reasons. In some embodiments, one or more components including the light-transducing component are highly elastic, stretchable polymer-based optical fibers, allowing axial movement of the light-transducing component without requiring redundant lengths of optical fiber. This advantage is particularly important in embodiments designed for use of the light-polymerizing patch material in conjunction with performing biopsies, endoscopies, bronchoscopies, laparoscopic procedures, or other subcutaneous or internal procedures. In some embodiments, the axial stretchability of one or more light-transducing components that have increased length compared to their original length is 2%, 3%, 5%, 10%, 100%, or some other percentage. This stretching force also reduces the likelihood of the components breaking or being retained during these procedures.

[0087] In some embodiments, the optically transmissive component is comprised of one or more components that may be less stiff than standard silica optical fiber tissue and optimized for a particular target procedure, tissue, organ, disease, some other use factor, or some combination thereof. Standard optical fiber has a Young's modulus of approximately 70 Gpa, which is much greater than the Young's modulus of healthy or diseased kidney tissue (approximately 30-60 kpa), liver tissue, breast tissue, gastrointestinal tissue, brain and nervous system tissue, blood vessels, and other tissues. The stiffness of standard silica optical fiber is particularly problematic when it includes any light-transducing material that extends distally beyond the tip of the needle, which may pose a high risk of blunt trauma to the tissue organ even if the tissue is shielded from sharp trauma by the needle. Also, the high Young's modulus of the standard optical fiber may propagate large blunt axial forces to the high strength photopolymerized gel, which may displace the patch material or cause other blunt trauma distally. If the Young's modulus of the optically transmissive component is much lower than that of normal tissue or organ, there may be a risk that the component will deform when exposed to arterial pressure bleeding. In some embodiments, one or more of the light conversion or waveguide components are made of a material having a Young's modulus of less than 30 GPa, 20 GPa, 10 GPa, 5 GPa, 1 GPa, 500 MPa, 100 MPa, 50 MPa, 10 MPa, 500 KPa, 100 KPa, 50 KPa, 40 KPa, 30 KPa, 20 KPa, 10 KPa, 5 KPa, 3 KPa, 2 KPa, 1 KPa, 0.5 KPa, 0.1 KPa, some other level, or some combination thereof. In some embodiments, one or more of the light diffusers are made of a material having a Young's modulus of less than 30 GPa, 20 GPa, 10 GPa, 5 GPa, 1 GPa, 500 MPa, 100 MPa, 50 MPa, 10 MPa, 500 KPa, 100 KPa, 50 KPa, 40 KPa, 30 KPa, 20 KPa, 10 KPa, 5 KPa, 3 KPa, 2 KPa, 1 KPa, 0.5 KPa, 0.1 KPa, some other level, or some combination thereof.

[0088] In some embodiments, one or more of the light conversion components are comprised of optical fibers of 1000 micrometers, 500 micrometers, 250 micrometers, 100 micrometers, 75 micrometers, 50 micrometers, some other size, or combinations thereof. In some embodiments, one or more of the optical fibers are biocompatible while being of the sizes listed above (or other optimized sizes), such that when used for a procedure such as a biopsy, the full diameter of the component is inserted subcutaneously or otherwise limits damage to the target tissue or organ, similar to devices currently used to perform biopsies.

[0089] In some embodiments, the device utilizes one or more of the following: a light-transmitting material, fiber, catheter, needle, rod, substance, coating, diffuser, accessory, motion-transmitting component, any other component, or any combination of these components made of biodegradable light-transducing material. This may allow for one or more of the following advantages: improved safety of the device or component, reduced local or remote toxicity, reduced cytotoxicity, biodegradable, reduced organ or tissue dysfunction, deeper or longer insertion or transmission into organ or tissue, reduced chance of mechanical damage, optimized photopolymerization, hemostatic effect, enhanced other specific mechanical properties, reduced regulatory barriers, reduced cost of disposable components, increased user preference, any other advantage, or combinations thereof. In some embodiments, one or more biodegradable light-transducing components are utilized. Light-transmitting biomaterials are particularly important for use in some embodiments that use light-transmitting components that extend distally, such as light-transmitting catheters, light rods, or other embodiments. All or some of these components extend beyond the needle or cutting portion of the device, significantly increasing the chance of compromising the cutting or holding portion of the device. Additionally, allowing partial polymerization of the patch material while a portion of the patch material is still in the lumen of a needle, light-conducting catheter, or other component (which allows the patch material to be tough and close under arterial bleeding conditions) increases the benefit of embodiments comprised of biocompatible light-transducing components to an unexpected extent.

[0090] These optically transmissive biocompatible materials may be comprised of one or more of poly-L-lactic acid (PLLA), poly-DL-lactic acid (PDLLA), polylactic acid (PLA), polydimethylsiloxane (PDMS), polyoctamethylene maleate citrate (POMC), poly(octanediol citrate) (POC), other citric acid containing polymers, polydimethyl-diphenylsiloxane (PMD-DPS), polyethylene glycol (PEG), polyacrylamide-alginate (PAAm-Alg), PEGDA, APBA, calcium alginate, cyclic olefin copolymers, conductive polyethylene, silk, cellulose, cells, bacterial cell-based optical fibers, hydrogels, polycarbonate, any other biocompatible optically transmissive materials, or any combination thereof.

[0091] In some embodiments, the material containing all or a portion of the light conversion component is subjected to one or more types of specific manufacturing methods, such as 3D printing of a particular document, casting, hot drawing, extrusion, spinning, electrospinning, some other manufacturing process, or a combination thereof.

[0092] In some embodiments, the light source is connected to the needle and / or located within the central lumen, component, or needle of the device. In some embodiments, the light source or diffuser is within the central needle. In some embodiments, the light source can diffuse light either within the needle lumen or instrument, or outside of those locations, or both. The advantages of combining both types have been discussed earlier in this application.

[0093] C. Optical elements In some embodiments, the light source is coupled to a flexible catheter that can propagate photons near the desired target location and then diffuse the photons to the target tissue, pathway, or other location in a simple or optimal manner. In some embodiments, the catheter comprises silica, fluorozirconate, fluoroaluminate, chalcogenide glass, crystalline material (e.g., sapphire), combinations thereof, or other suitable materials. The catheter may be located outside the external cutting needle, between the needles, or within one of the needles. In some embodiments, the light diffusing catheter extends to near or beyond one or more of the tips of the inserted needles, allowing some radial force to be applied during the time the catheter is in the extended position, or alternatively, it may be more flexible and only lateral pressure to be applied while the patch material is pumped through its central lumen. The light catheter also allows partial curing of the patch material before it is exposed to turbulent bleeding or wet tissue, reducing the viscosity and rheology requirements required for the unpolymerized patch material and improving ease of delivery. Additionally, light diffusing catheter embodiments have the unexpected advantage of providing radial traction on the tissue, thereby reducing the degree of bleeding or disruption of surrounding tissue and allowing time and distance for light polymerization to occur before exposure to arterial blood pressure. This improves the likelihood of a strong closure, thus allowing the large diameter and / or cutting needle to be withdrawn slightly or significantly proximal to the biopsy site. Withdrawing the needle into the light diffusing catheter prevents the needle from causing further trauma to the target tissue, retracts sharp components from dangerous organs or tissues, covers the tube tip, and provides other benefits.

[0094] In some embodiments, photons are guided from a light source to a light emitter or target through a single fiber optic cable, a microlens array, a collimating microlens, a fused silica microarray, two types of fiber optic glass, single mode and multimode, photonic crystal fiber for nano-optical fiber, two and three photonic crystal fibers with multiple air channels that can hold material, multiple fiber optic cables, or combinations thereof.

[0095] In some embodiments, the optical fiber nanofiber comprises a section having a diameter of the optical wavelength. In some embodiments, the fiber optic cable comprises a tapered section to allow for splicing. In some embodiments, the optical element comprises a material that has been treated with a chemical treatment, such as exposure to molecular hydrogen, to reduce solarization of the optically transparent component. In some embodiments, the optical element comprises a nano-optical fiber having a Bragg or long period grating, but also other mode selection schemes (i.e., photonic lanterns and patterned waveguides).

[0096] In some embodiments, the optical element comprises a material that includes light diffusion enhancing nanoparticles, such as aluminum, copper, gold, or silver nanoparticles. In some embodiments, the optical element comprises graphene. In some embodiments, the optical element comprises a graphene-based FET that is believed to be biocompatible and chemically stable. In some embodiments, the graphene functional field effect transistor is used to detect a specific protein or substance.

[0097] In some embodiments, one or more of the materials comprising the catheter material, or a combination thereof, are acoustically attenuating and heat resistant. These embodiments have the advantage that they can denature tissue to cauterize bleeding and isolate the tissue denature area to a portion of the distal end of the needle. In some embodiments, the material is PEEK, ULTEM, some other acoustically attenuating and heat resistant material, or a combination thereof.

[0098] In some embodiments, one or more of the portions of the device that are acoustically attenuating and heat resistant also include one or more portions of the device that are operatively connected to the waveguide, the optical diffuser. For example, some embodiments use acoustic ablation in combination with a catheter incorporating an optical waveguide, which can protect the portions of the device from the heat and vibrations associated with high intensity focused ultrasound (HIFU), as well as protect the tissue from their effects. This allows for a synergistic repair effect by isolating the target tissue, reducing local migration and embolization of the patch material, allowing for the use of less patch material that can still polymerize in areas that are highly bleeding from hydrostatic pressure, reducing the amount of HIFU denatured tissue, protecting the remaining portions of the tissue, and protecting the integrity of the waveguide.

[0099] 1. Stretchable waveguides In some embodiments, the device includes a biodegradable waveguide that constitutes the entirety of the waveguide or a portion thereof. In some embodiments, the device includes a biocompatible waveguide that constitutes a different set length less than 20 cm, 15 cm, 14 cm, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, 1 cm from the distal end of the waveguide, or any combination thereof. In some embodiments, the device includes a biodegradable waveguide that constitutes a different set length less than 20 cm, 15 cm, 14 cm, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, 1 cm from the distal end of the waveguide, or any combination thereof. The most prone portion of the needle to bend during the procedure is the distal 3-5 cm length, particularly applicable to large internal needle biopsy needles for kidney, liver, prostate, solid mass, and biopsy. This type of biopsy needle is vulnerable to distal rotational and twisting forces in the biopsy trough. Bone biopsies are also often affected. When the needle is bent (during the photopolymerized patch test procedure), the conventional glass waveguide contained within the needle is likely to fracture and then break off in the living tissue. This may require surgical retrieval to prevent secondary damage in the living patient. This problem is solved by using a biodegradable waveguide, which is less likely to fracture upon bending and does not require surgical retrieval. However, the high internal optical resistance of the biodegradable waveguide limits its use to the distal portion of the device, thereby limiting the total decibel loss of light intensity.

[0100] In some embodiments, the device includes two or more types of non-silica based waveguide materials to close a surgical wound using a photopolymerized patch material. In some embodiments, the device includes two or more types of biodegradable waveguide materials to close a surgical path, a biopsy path, a puncture path, other path, or any combination thereof using a photopolymerized patch material. In some embodiments, the device includes two or more types of biodegradable waveguide materials to deliver photons and activate the photopolymerized patch material to close a biopsy wound.

[0101] In some embodiments, the device comprises a light diffuser made of a biodegradable material. In some embodiments, the type of biocompatible light guide is based on the type of photoinitiator and the target spectrum of light. In some embodiments, the waveguide comprises a polyoctamethylene maleate citrate (POMC) core with a polyoctamethylene citrate (POC) cladding.

[0102] Figures 3A-3E illustrate a biopsy needle with a biodegradable waveguide (305), according to some embodiments. In some embodiments, the waveguide is translatable through a portion of the needle, as shown in Figures 3A-3C. In some embodiments, the patch material passes around the waveguide, as shown in Figures 3A and 3B. In some embodiments, the waveguide is configured to emit or exit bath light at multiple angles, as shown in Figures 3A, 3C, and 3D.

[0103] In some embodiments, the light source is connected to the needle and / or located within the central lumen, component, or needle of the device. In some embodiments, the light source or diffuser is in the central needle. In some embodiments, the light source can diffuse light either within the needle lumen or instrument, or outside of those locations, or both. In some embodiments, one or more of the materials, including the catheter material, or a combination thereof, are acoustically attenuating and heat resistant. In some embodiments, the material is PEEK, ULTEM, some other acoustically attenuating and heat resistant material, or a combination thereof.

[0104] In some embodiments, one or more of the portions of the device that are acoustically attenuative and heat resistant also include one or more portions of the device that are operatively connected to the waveguide, the optical diffuser. For example, some embodiments use acoustic cauterization in combination with a catheter that incorporates an optical waveguide, which can protect the portions of the device from the heat and vibrations associated with HIFU, as well as protect the tissue from their effects. This allows for a synergistic repair effect by isolating the target tissue, reducing local migration and embolization of the patch material, allowing for the use of less patch material that can still polymerize in areas that are highly bleeding from hydrostatic pressure, reducing the amount of HIFU denatured tissue, protecting the remaining portions of the tissue, and protecting the integrity of the waveguide.

[0105] In some embodiments, one or more light conversion portions of the device are heat and HIFU resistant. In some embodiments, one or more portions of the waveguide, light diffuser, both, or a combination thereof are biodegradable, and one or more portions are covered, attached, coated, closed, or otherwise associated with a material or substance that is heat and HIFU resistant. To prevent hemorrhage in patients with progressive diseases, such as progressive renal disease, these patients may need to undergo multiple or lengthy tissue closure steps to prevent hemorrhage. These multiple steps may cause repeated damage to the photon propagating portion of the device, increasing the chance of failure and increasing the chance of portions of the device remaining in the diseased tissue. Having a combination of a biodegradable photon propagating portion and a HIFU and heat resistant material allows for longer and stronger tissue closure in situ. In some embodiments, the device comprises a stretchable waveguide for activation of patch material, analysis of patch material, analysis of biopsy, analysis of biological material, optical biopsy, transmission of photons from a proximal location to a distal location, reception of photons from a distal location to a proximal location, some other interaction, or a combination thereof.

[0106] In some embodiments, the stretchable waveguide includes one, two, or more mirrors, reflectors, couplers, waveguide connections, stretchable waveguide sections, stretchable waveguide sections, sliding waveguide sections, light sources, low-friction components, stretchable elements, other components, or some combination thereof.

[0107] In some embodiments, the stretchable waveguide is present within the main housing of the device, external to the main body of the device, within the needle cartridge of the device, within the needle, within the lumen, within the instrument cartridge of the device, within the drive component, actuator component, within the power supply of the device, within the light source cartridge of the device, or some other location, or combination thereof.

[0108] In some embodiments, the device includes a waveguide that can be quickly extended or retracted. In these embodiments, the device can excise a biopsy at at least the same distal linear cutting speed as a conventional automated biopsy device. Also required for the waveguide incorporated in the rotary cutting and vacuum assisted embodiment of the device is a waveguide that does not impede any reduction in rotation speed, rotation force, distal drive speed, vacuum flow rate, or vacuum force. Even a 15-20% increase in the mass of the cutting portion of the device or the drive force required can significantly compromise the quality of the biopsy specimen.

[0109] In some embodiments, the rapidly extendable waveguide comprises a coaxial telescopic mechanism. In some embodiments, the waveguide is made of components that are oriented parallel to their respective axes and can be slidably extended. This allows the waveguide to be extended in one direction while still being made of a relatively rigid structure. This also allows the unrecognized advantage of allowing the use of inexpensive waveguides such as gas or liquid surrounded by a reflective cladding while still extending the length of the waveguide for instrumentation or patches distal to the housing or starting point of the device. These components can also be of great advantage in embodiments made of disposable components to reduce costs, especially those involving the use of disposable cartridges, needles, waveguides, or components.

[0110] In some embodiments, the tubular cladding system provides distal flow of gas, liquid, vacuum force, or combinations thereof.

[0111] In some embodiments, the device comprises a stretchable waveguide with low mass. In some embodiments, the waveguide is a hollow stretchable waveguide with reduced mass compared to the mass of an optical fiber. In some embodiments, this includes one or more hollow sections of the waveguide where one waveguide telescopes into another. In some embodiments, the stretchable section of the waveguide allows the device to reach the appropriate wavelength to activate the photopolymerized patch material in one or more confined sections of the device.

[0112] In some embodiments, the device comprises a stretchable waveguide with one, two, or more biodegradable photon diffusers or projectors. These may be coupled to hollow or solid stretchable sections of the device. In some embodiments, the device comprises a stretchable waveguide with a variable diameter lumen such that light is altered to a desired wavelength to activate polymerization of a patch material within any portion of the device, needle, catheter, other component, or combination thereof. In some embodiments, the waveguide comprises a component capable of extending the waveguide in the direction of the instrumentation.

[0113] In some embodiments, the device comprises a low friction waveguide. In some embodiments, the device comprises a telescoping waveguide that is an integral part of one or more needle drive mechanisms. In some embodiments, the light source is integrated into the telescoping portion of the device. In some embodiments, the light source, or a component that generates or provides energy to the light source, is an integral part of the needle drive component.

[0114] When using conventional fiber optic cables, the mass of the optical fiber and the force required to straighten the curved section can impair the speed or cutting force, thereby interrupting the biopsy cutting operation. Conventional optical fibers can also occupy excessive amounts of space within the device, reducing the space available for the biopsy drive mechanism. Light source or waveguide components with low mass, hollow, low friction, or other force reducing components increase the likelihood of a successful biopsy. It also reduces the risk of biopsy column splitting, increases the width and length of the biopsy column, reducing the number of biopsies required and improving their efficiency. By integrating the waveguide or waveguide coupler into the biopsy drive mechanism, plunger, needle connector, needle axis control, biopsy control mechanism, or biopsy needle actuator, this component provides these above-mentioned advantages, but also ensures close coupling of the waveguide portion from the light source to the needle, and acts synergistically with the photopolymerized patch material to reduce the possibility of excessive bleeding (by slowing down the biopsy cut speed or preventing a reduction in the cut force) by preventing visible tissue lacerations that are difficult to close with the photopolymerized gel.

[0115] In some embodiments, there is a sensor integrated into the stretchable waveguide. In some embodiments, multiple light sources may be integrated into one light source.

[0116] In some embodiments, the waveguide is stretchable and slotted. In some embodiments, the waveguide is slotted in two or more places. In some embodiments, there is a lateral connection between two waveguides such that light is carried from one section to the other by a light bending section of the waveguide. In some embodiments, the light bending section of the waveguide comprises a portion of a biopsy needle. In some embodiments, the light bending section of the waveguide comprises a distal drive connection to one or more portions of the biopsy needle. In some embodiments, the stretchable waveguide comprises a connection between the light source and the distal half of the needle via a lateral waveguide connector.

[0117] In some embodiments, the connections between the optical fibers are made with MTP (multi-fiber termination push-on), MPO fiber optic connectors, LC connectors, SC connectors, FC connectors, ST connectors, MT-RJ connectors, or combinations thereof.

[0118] In some embodiments, the shape of the waveguide is circular, square, rectangular, some other shape, or includes multiple sections of various shapes in cross section. Figures 39A-D illustrate various embodiments of one or more waveguides (3905) and tubes (3910) for delivering biocompatible patch material through the lumen of the needle. Figure 39A illustrates a waveguide (3905) and tubes (3910) contained within a circular cross section of the lumen, according to some embodiments. Figure 39B illustrates multiple waveguides (3905) and tubes (3910) contained within a circular cross section of the lumen, according to some embodiments. Figures 39C and 39D illustrate a waveguide (3905) and tubes (3910) shown with partial or semicircular sections, according to some embodiments. These embodiments may correspond to the placement of the waveguides and tubes in a section of the lumen adjacent to the specimen tray of a biopsy needle as disclosed herein. In some embodiments, as shown in Figure 39C, the surface (3912) of the waveguide (3910) is exposed to allow emission of light from the surface (3912).

[0119] 2. Release In some embodiments, the light is emitted from one or more locations on the needle, such as the tip of the needle, the side of the needle, the shaft of the needle, the inner lumen of the needle, the cutting sheath of the needle, the biopsy portion of the needle, the face of the instrument facing a particular anatomical location, the surface of a vascular instrument, the surface of an introducer, some or all of a forceps, or a combination thereof.

[0120] 3. Optical fiber materials In some embodiments, the optical fiber material comprises erbium, ytterbium, erbium ytterbium, thulium, neodymium, telecom fiber, or combinations thereof. In some embodiments, the optical element comprises a liquid optical fiber, an optical nanowire, an optical fiber laser, silica, glass, crystal, or combinations thereof. In some embodiments, the optical nanowire is configured to only let half the light out the side.

[0121] 4. Photon Wavelength In some embodiments, the wavelength of the emitted photons is in the UV spectrum, the visible spectrum, the infrared spectrum, other wavelengths, or some combination thereof. In some embodiments, a 360 nm UV spectrum is used to activate the gel. In some embodiments, the far UV spectrum is utilized because it is still high in energy and can rapidly activate the photopolymerized gel (in some cases in less than 5-10 seconds), but is known to be safe for mammalian tissue and eyes, penetrating only a few micrometers into living tissue. In some embodiments, the wavelengths used to activate the photopolymerized patch material are 365 nm to 405 nm, 400 nm to 450 nm, 385 nm to 420 nm, or sometimes activation is performed at different wavelengths.

[0122] D. Fluid circuit In some embodiments, the biocompatible patch-based material is delivered via pneumatic, thermal, photothermal (i.e., one wavelength expands / emits while another does the curing), mechanical, electrical, piezoelectric, magnetic, capillary, or combinations thereof. In some embodiments, there are one or more components within the housing, body, needle, or other components or portions of the device that can be used to advance the patch material through the small lumen of the needle or other instrument, despite its high viscosity. These may include one or more components such as a plunger, peristaltic pump, helical pump, gear pump, centrifugal pump, hydraulic mechanism, air pump, liquid pump, internal or external balloon, or combinations of those components.

[0123] In some embodiments, the timing and / or location of release, the type and / or types of substance(s) released or delivered, the amount, type, types, associated features of the release of photoactive substance may be one or more times, may have one, two or more manual triggers, may have one, two or more manual triggers, may be timed relative to a particular tissue, includes automatic timing by the device, includes manual timing by the device, includes semi-automatic timing by the device, includes timing relative to the release of photoactive substance, includes timing of immediate release of photons, includes timing of delayed release of photons, and sometimes no photons are released at all.

[0124] In some embodiments, the release of the patch material is timed with timing relative to the input measurement to the extent that a procedure is completed, or any combination thereof, before, during, or after a needle is inserted, or any combination thereof, before, during, or after a tubular structure is implanted, or any combination thereof, a section of a needle and / or instrument that is implanted into an organ, a particular part of an organ, a tumor, a particular part of a tumor, and / or a biological structure, a needle that is implanted into the skin, when a heating process is performed, when freezing is performed, before, during, and / or after a biopsy is taken, before, during, or after a substance is released from the needle or instrument, or any combination thereof, before, during, or after a distance from contact with a surrounding organ, part of an organ, vascular tissue, biological structure, substance, body, a chemical, physical, biological, thermal, cooling, electrical, or photon activation process occurs, or any combination thereof. For example, in some embodiments, the extent to which the substance has undergone photochemical activation can be detected using an optical input interrogating the target area, and the device may notify the user of its progress and / or make computer-based and / or computer-assisted decisions regarding the timing and / or duration of photon emission from the device. In some embodiments, the fluid flow path for delivering the patch material is configured to reduce turbulence. In some embodiments, the final portion of the patch material that is emitted does not include a photoinitiator, for example to prevent unwanted adhesion to the device.

[0125] In some embodiments, the timing is relative to a sensor-related input that measures the extent to which a chemical, physical, biological, thermal, cooling, electrical, or photon activation process has occurred. For example, in some embodiments, the extent to which a substance has undergone photochemical activation can be detected using an optical input that interrogates the target area, and the device may notify a user of its progress and / or make computer-based and / or computer-assisted decisions regarding the timing and / or duration of photon emission from the device.

[0126] The timing is related to the shape, structure, narrowing, internal flow, internal pressure, luminal wall pressure, hemorrhage, osmotic pressure, physiology, pathophysiology, damaged portions, defective portions, removed portions, excised portions, manipulated portions, added portions, repaired portions, surgical portions, and / or other features of the tubular body that are sensed, detected, calculated and / or presented by the user and / or computer software and / or that will be performed.

[0127] In some embodiments, the timing is relative to the shape, structure, narrowing, internal flow, internal pressure, luminal wall pressure, hemorrhage, osmotic pressure, physiology, pathophysiology, damaged portion, missing portion, removed portion, excised portion, manipulated portion, added portion, repaired portion, surgical portion, and / or other characteristics of a portion of an organ that are sensed, detected, calculated and / or presented by the user and / or software.

[0128] In some embodiments, the timing is relative to the shape, structure, stenosis, internal flow, internal pressure, luminal wall pressure, hemorrhage, osmotic pressure, physiology, pathophysiology, damaged portion, missing portion, removed portion, excised portion, manipulated portion, added portion, repaired portion, surgical portion, and / or other features of the organ as sensed, detected, calculated and / or presented by the user and / or computer software.

[0129] In some embodiments, the device is configured to prevent photoactive substances from adhering to the device. In some embodiments, photons received by the device from the tissue are used to determine one or more of a diagnosis, a prognosis, a severity of disease, guide a recommended treatment, a response to treatment, a need to modify a drug or treatment, and / or to determine the type, intensity, duration and / or cause of tissue and / or pathway occlusion.

[0130] In some embodiments, the area of ​​light activation is offset a distance away from the device, instrument, housing, and / or needle. For example, two light activations at a specific distance from the instrument. This allows the light-activated material to close tissue without closing the instrument itself. In some embodiments, the device can use this feature to create detailed 3D prints in and / or on living tissues and / or structures. For example, repairing or stenting blood vessels, repairing and / or replacing ear structures, replacing biopsy tissue fragments and masses.

[0131] In some embodiments, the timing is relative to the insertion of the needle into the biological tissue, the retraction of the needle from some and / or all of the biological tissue, interaction with a particular tissue, or a combination thereof.

[0132] 1.Multi-drive system In some embodiments, the device couples the actuation of patch material delivery, tissue modification, or both to other parts of the device. In some embodiments, this includes coupling the injection and activation of the patch material to one, two, three, or more drivers. These drivers can be biopsy actuation steps, such as those in an automated large needle biopsy device. For example, in some embodiments, a user may trigger the firing of a biopsy, thereby actuating a first drive spring to advance the inner needle to the target site. As this first spring approaches maximum extension, it can push the retaining portion to release it from the retaining state and actuate a second drive spring. In some embodiments, there are additional connections that are either coupled to all actuations or toggled on or off by the user, as shown in the associated drawings. When the patch material delivery coupling mechanism is toggled (or permanently unlocked) to the on position, the activation cascade caused by the biopsy activation can trigger one or more of the following actions: mixing of the patch material, activation of the patch material within some portion of the device, release of the patch material, activation of the patch material somewhere outside of the device, advancement of some portion of the device (such as a plunger), rotation of some device (such as a pump mechanism), electrical activation of the illumination system, electrical activation of the RF ablation, electrical activation of the HF ultrasonic ablation, retraction of the needle, retraction of the sheath, retraction of the catheter, retraction of some other portion of the device, advancement of some portion of the device, an ablation step, or any combination thereof. This allows the user to rapidly activate the patch delivery and activation mechanism to ensure that a portion of the tissue damaged by the biopsy (or related procedure) is intimately coupled. This is beneficial in preventing arterial bleeding associated with biopsies and in providing precise and repeatable results of mixing the patch material and partially polymerizing within some portion of the device. In some embodiments, a third driver in the system couples the triple driver to the retraction of one or more elements of the device, and this retraction action mechanically results in the injection and advancement of patch material, may advance a plunger, or may cause rotation of a pump component.In some embodiments, the coupling mechanisms and components between each of the drivers may include one or more of mechanical displacement of a retaining element, axial motion, rotational motion, vacuum pressure, outward motion of an advancing surface, electrical actuation, magnetic actuation, piezoelectric actuation, mechanical-electrical, or some combination thereof. In some embodiments, the drivers comprise one or more springs, electric motors, piezoelectric motors, other stored mechanical energy, other stored electrical energy, other drivers, or some combination thereof.

[0133] In some embodiments, one or more of the triple actuation systems are mechanically coupled to a cocking (reset system). In some embodiments, the reset system reloads patch material into the device, reprimes patch material into the device, resets the needle from a retracted position, resets the needle from a distal position to a "read position", actuates an ablation process, pushes out a portion of the device, exposes a biopsy specimen to the user, charges a battery, charges a capacitor, or some combination thereof.

[0134] In some embodiments, there is a preferred sequence of events for the triple drive actuation and reset for use and actuation with one-handed cocking. In some embodiments, actuation causes the inner biopsy needle to be fully extended, and then the first drive actuates the second drive at full extension, thereby advancing the outer biopsy needle to excise the biopsy specimen to be cut from the target tissue. This second drive then causes actuation of the third drive, simultaneously retracting both needles in unison from the target site at a controlled rate as the patch material delivery system advances to activate the patch material. This patch material activation may occur within the bore of the needle, within a portion of the device such as within the catheter, outside a portion of the device, or at multiple locations, etc. This combination is preferred for biopsy and tissue closure devices using light-polymerized patch materials with strong adhesion forces that exceed the forces of hypertensive arterial blood pressure bleeding. Also, the cocking process coupled with this exemplary triple drive system has a cocking sequence that can be set with one hand using a cocking lever system and reset mechanism in some embodiments. In some embodiments, once withdrawn from the patient, the user may pull the lever once to return the two needles to a non-retracted position, thereby resetting the biopsy needle and repriming it with patch material. A second actuation of the cocking lever then retracts the outer needle, thereby exposing the specimen in the inner needle trough. A third actuation of the cocking lever then returns the inner needle to its initial position and prepares the activation button for use.

[0135] In some embodiments, various other configurations and timings exist. For example, when used for breast biopsy, the device may have only one needle drive mechanism followed by a specimen vacuum mechanism. In such cases, it may be preferable to deliver the patch material using a rotary cutting action, for example, an internal rotor exposing a low profile waveguide and a rotary patch pump that retracts the inner needle and biopsy specimen to a terminal distal position.

[0136] 2. Control of patch delivery mechanism In some embodiments, the device includes a system for the user to control the release of the patch material, such as toggling the patch material on, off, increasing the duration, decreasing the duration, other modifications, or combinations thereof. This can be important because the user may not want to use the patch material process on every pass of the instrument. This can be important because the user may only want to close the common biopsy path formed at the last pass. This can be an unexpected advantage when using patch single dose or limited dose cartridges, allowing more biopsies to be performed using a single cartridge.

[0137] In some embodiments, the device comprises a limited number of patch doses. In some embodiments, the patch material can only be used to close the puncture path of one, two, or some other limited number of needle passes or instrumentation. In some embodiments, the patch material can only be used to close the puncture path of one, two, or some other limited number of needle biopsies. In some embodiments, the release / activation of the patch material is controlled by a switch, knob, roller, dial, button, touch screen, sensor, computer process, output, automatic control, semi-automatic control, remote control, other mechanism, or some combination thereof. In some embodiments, these inputs may be used to control mixing, pumping, extrusion, activation, other mechanisms related to the patch material, or combinations thereof. This timing and sequencing change is also an advantage for users who do not want to use the patch function at every needle pass.

[0138] In some embodiments, the device includes a physical mechanism for coupling, decoupling, or otherwise altering the interaction of the release and hardening of the patch from other mechanisms of the device, or a combination thereof. In some embodiments, the device includes a physical mechanism for coupling, decoupling, or otherwise altering the interaction of the release and hardening of the patch from the biopsy action of the device, or some ...

[0139] In some embodiments, the device includes a control for resetting the device to perform another procedure. In some embodiments, the control is automatic, while in other embodiments, there is a lever, button, handle, crank, switch, combinations thereof, or some other means of resetting to operate the device. In some embodiments of the device, the cocking mechanism is mechanically, electrically, or otherwise coupled to the initial priming or repriming of the patch material system such that the action also prepares the patch material system. Instead, in some embodiments, priming the device for use with the patch material resets the drive mechanism, thereby cocking the device. In some embodiments, the action of loading or unloading a needle, instrument cartridge, patch cartridge, optical cartridge, any other component, or combination thereof, into or out of a portion of the device activates the cocking mechanism and prepares the drive action for use.

[0140] In some embodiments, the drive mechanism also generates electrical, mechanical, electromechanical, piezoelectric, magnetic, or elastic energy to provide power to the light source of the device, which may reduce recharging requirements or improve performance under stringent conditions.

[0141] 26A-34 illustrate various embodiments of fluidic components for controlling the delivery of patch material, according to some embodiments, each of which may be considered to have the advantage of dispensing the patch material in small increments.

[0142] Figures 22A-22D illustrate a plunger that translates to push the patch material out of the outer lumen of the fluid delivery component. Figures 22A-23D show that the expansion properties of a material under heat can be utilized to drive a fluid system.

[0143] 24A-25E illustrate various embodiments of vertical translation systems for translating components of the patch material and / or biopsy needle.

[0144] FIG. 26A illustrates a fluid drive system having a locking groove that prevents the drive mechanism from backing up due to back pressure.

[0145] 26B-26C illustrate a fluid drive system in which rotation of a component is translated into vertical motion of a fluid.

[0146] FIG. 27A illustrates a rotating gear and corresponding rack system that drives the patch material out of the end of the lumen.

[0147] FIG. 27B illustrates a two-stage translation system that drives a patch material, or multiple patch materials, from the end of the lumen.

[0148] FIG. 27A illustrates a rotating gear system that drives the patch material out of the end of the lumen.

[0149] 28A-28B illustrate a method for delivering multiple patch materials, where the delivery of each patch material may be individually controlled.

[0150] 29-30 illustrate a system for delivering different concentrations of different patch materials through a common lumen. In some embodiments, internal features are added to ensure that the patch materials are thoroughly mixed.

[0151] FIG. 31 illustrates a system for delivering patch material in small increments utilizing a sliding rack that engages a rotatable wheel.

[0152] FIG. 32 illustrates a system for delivering patch material in small increments utilizing a locking sliding rack.

[0153] FIG. 33 illustrates a system for delivering patch material in small increments utilizing a two-stage translation actuator.

[0154] FIG. 34 illustrates a system for delivering patch material in small increments utilizing a selectively disengageable rotating gear system.

[0155] 3. Timed retreat In some embodiments, one or more portions of the device include a timed retraction mechanism. In some embodiments, the timed retraction mechanism includes one or more components used to optimize the closure strength, flexibility, tensile strength, configuration, Young's modulus, curing, dispensing, mixing, rate of formation, any other portion of the light polymerized patch material, or combinations thereof. In some embodiments, the timed retraction mechanism is used to optimize the closure, curing, dispensing, or any other aspect of the patch material. In some embodiments, the timed retraction mechanism is used to optimize the closure of the patch material in addition to tissue degenerative actuation. In some embodiments, a patch material cartridge attached to the device automatically adjusts the timing mechanism. In some embodiments, a power cartridge attached to the device automatically adjusts the timing mechanism. In some embodiments, an instrument cartridge attached to the device automatically adjusts the timing mechanism. In some embodiments, the device comprises a sensing component of the device that monitors closure of the curing aspect within a portion of the device that modifies the timing mechanism through a central feedback system. In some embodiments, there is a sensing component of the device that monitors closure of the curing aspect within a portion of the device.

[0156] In some embodiments, the viscosity of the patch material resists the force of a plunger, pump, spiral pump, fluid, air, propeller, any other component, or combination thereof, slowing down the mechanical retraction of the distal end of the device while the patch material is polymerized and extruded from a portion of the device, thereby optimizing the exposure time for curing.

[0157] In some embodiments, the device includes a mechanism whereby one, two, or more catheters are retracted more slowly than one, two, or more needles while the patch material is partially or completely polymerized within the lumen of the catheter. This allows the patch to form, stretch, thicken, strengthen, and propagate while in the lumen of the device. This allows for the formation of a continuous column of photopolymerized patch even in a generally liquid environment distal to the distal open end of the catheter and / or needle. These advantages are particularly useful when patching biopsies in the kidney, liver, prostate, breast, brain, or gastrointestinal tract, as this mechanism can be used to form a patch distally to occlude blood vessels, veins, arteries, AV fistulas, false, pseudoaneurysms, meninges, or other fluid containments that the distal end of the blood vessels enters. This mechanism may be used to initiate the patch material, thereby creating a distal anchor, or may be used during all or a portion of the patch curing process, and may help create a column of solid patch material during all or a portion of the biopsy tract.

[0158] Other timing combinations that provide the same benefits may include the following variations: in some embodiments, the device includes a mechanism whereby one, two, or more needles are retracted slower than one, two, or more catheters while the patch material is partially or fully polymerized within the lumen, beyond the external opening, or both. In some embodiments, the device includes a method whereby one, two, or more catheters are retracted while the patch material is polymerized within the lumen of the catheter, distal to the external opening, or both. In some embodiments, the device includes a method whereby one, two, or more needles are retracted while the patch material is polymerized within the lumen of the needle before being released from the distal end.

[0159] In some embodiments, the device uses mechanical components to create a timed (or extended) retreat while generating electricity, which can be particularly useful in non-existent parts of the world.

[0160] In some embodiments, the device includes a system that allows the user to control the timing mechanism by toggling it on or off, increasing the duration, decreasing the duration, or making other modifications, or a combination thereof, to change the timing mechanism. This can be important since the user may use the device to achieve different effects with the patch material, such as hemostasis versus tissue closure, and may be controlled to optimize the timing mechanism for a particular organ, anatomy, disease state, electronic display, sensor reading, calculation, output, other reasons, or combinations thereof. In some embodiments, the change in the timing mechanism of the device is controlled by a switch, knob, roller, dial, button, touch screen, sensor, computer process, output, automatic control, semi-automatic control, remote control, other mechanism, or combinations thereof. In some embodiments, these may be used to prevent a mechanism from being implemented, essentially turned off or on, or otherwise changing any mechanism of the device. This change in timing and sequencing is also an advantage for users who do not want to use the patch function at every needle pass. This can have the unexpected advantage of preventing some visible or non-visible portion of the patch material from adhering to a portion of the biopsy device, thereby altering the smooth biopsy action of the next biopsy excision that may be performed after photopolymerization.

[0161] In some embodiments, the device includes a system that allows the user to control a timing mechanism so that one or more components are pulled against the surface of biological tissue during advanced renal disease. This allows the patch material to have an increased tensile strength, which can better match the tensile strength of fibrotic renal tissue and better withstand hypertensive arterial bleeding. It also allows for longer polymerization in any lumen of the device before exposure to tissue to compensate for the lack of natural hemostatic mechanisms and lack of vascular elasticity in advanced renal disease.

[0162] 4. Patch Priming Process In some embodiments, the device includes a priming mechanism for preparing the device for use. In some embodiments, the device includes components used to prepare the patch material for injection. In some embodiments, the priming process includes one or more components including mixing the patch material, moving the patch material to a distal portion of the device, checking the patch material composition with a sensor, moving the plunger to a set point, moving the patch material with a pump, checking the light intensity, checking the light wavelength, changing valves, changing filters, other patch material components, changing indicator displays, changing the visible patch material window, or any combination thereof.

[0163] In some embodiments, the patch priming process includes activation of one or more light sources within the device, partial polymerization of the patch material, full polymerization of the patch material, denaturation of other patch material components, or some combination thereof, which allows the patch material to better close in the setting of hypertensive arterial bleeding, organ disease that interferes with normal hemostatic processes. In some embodiments, the patch priming process includes a temperature change to one or more of the patch material components by heating, cooling, normalization, or some combination thereof.

[0164] In some embodiments, the device includes patch priming steps specific to one or more issues related to the intended patient, organ, disease etiology, disease severity, disease progression, hemophilia, coagulation disorders, platelet disorders, use of anticoagulant drugs, use of antiplatelet drugs, use of other drugs, Platelet Time testing, International Normalized Ratio, any other measure, or any combination thereof.

[0165] In some embodiments, the device includes one or more controls that a user can adjust to select an optimized patch priming process operation. In some embodiments, the device includes a simplified patch priming process selection that is limited to one or more simplified selection options. These selection options may include one or more of a numerical selection, a qualitative selection, an organ selection, a disease selection, a coagulation selection, a blood pressure selection, a platelet disorder selection, or any combination thereof.

[0166] In some embodiments, the device includes one or more automatic control adjustments for selecting an optimized patch priming process operation. These automatic control adjustments for optimizing the patch priming process operation may consist of a sensor-triggered output detecting a change in the patch material, a power cartridge selection, a patch material cartridge selection, a light source selection, a light source sensor, a computer-based calculation, an external sensor, an internal sensor, a component position, a user-controlled position, an aspect of the patient detected by a sensor, an aspect of the biological tissue detected by an imaging device, a guidance system, some other component, or some combination thereof.

[0167] In some embodiments, the device includes a patch priming step that can be activated one or more times by the user before a procedure, after attachment of the module, during a procedure, after a procedure, or some combination thereof. In some embodiments, the patch priming step can be manually activated by the user to prepare for closure before the device is fully withdrawn after a biopsy. This allows the user to selectively prime the device after a biopsy, thus preventing the user from altering the normal biopsy process and mechanics that would be altered by priming or partially polymerizing the patch material.

[0168] 5.Excision process In some embodiments of the device, the device comprises one or more ablation steps used to help clear debris from a portion of the device during use. In some embodiments of the device, the device comprises one or more ablation steps during the instrumentation process and patch placement. In some embodiments of the device, the device comprises one or more ablation steps after the cauterization process and patch placement on the wound. In some embodiments of the device, the device comprises one or more ablation steps during biopsy specimen collection and patch placement on the wound. In some embodiments, the ablation step may be used one or more times while a portion of the device is still within tissue, other biological material, before use, during use, after use, between uses, or some combination thereof. In some embodiments, the ablation step uses one or more frequencies of photons to sever chemical bonds, mechanical bonds, physical bonds, other bonds, or some combination thereof. In some embodiments, the ablation step is used to help clear debris from one or more needles, biopsy needles, internal biopsy needles, external biopsy needles, light diffusers, waveguides, catheters, sheaths, lumens, interiors, exteriors, coatings, tissues, materials, other targets, or some combination thereof. The ablation step may be performed in some embodiments by one or more methods of material ablation, such as photoablation, heating, vibration, RF electrosurgery, HIFU, thermal cauterization, freezing, some other energy delivery, mechanical brushing, mechanical sweeping, some other mechanical method, or a combination thereof. In some embodiments, the ablation step may be used to release one or more portions of the distal portion of the device from the occluded patch material or tissue. Alternatively, it may be used to prevent debris from releasing the patch material or interfering with mechanical function during the next procedure. Alternatively, it may be used to extend the life of the device or prevent contamination of the current or next biopsy specimen. This step may also be used to prevent mechanical frictional forces for the next procedure associated with the presence of the patch material. This may help prevent frictional forces from the patch material even if present at concentrations below the level visible to the human eye. Alternatively, it may be used to prevent contamination of a biopsy specimen that has already been removed from the tissue before the ablation step but remains within some portion of the device.

[0169] When used after a large needle biopsy procedure and patch material placement performed in some embodiments of the device, the cutting step may be used to help remove the patch material from the outer biopsy needle, the inner needle, other parts, or combinations thereof. When used after a large needle biopsy procedure and photopolymerized patch material placement performed in some embodiments of the device, the cutting step may be used to help remove the patch material from the outer biopsy needle, the inner needle, other parts, or combinations thereof. Most large needle biopsy procedures are semi-automated using mechanical drive components such as springs to power the biopsy specimen collection. When activated, these springs generate a driving force that slides and translates the needle axially forward over another needle at a consistent rate to cut out tissue. However, any increase in friction between these needles causes an exponential increase in failure of the biopsy procedure. Then, when the biopsy trough is opened to retrieve the biopsy specimen after the cutting step, the risk of unsightly contamination of the patch material of the biopsy specimen is significantly reduced. In some embodiments, the cutting step may be used after one or more biopsy procedures utilizing a rotating biopsy needle. This prevents unseen portions of the patch material from damaging the biopsy specimen due to increased friction of the rotating needle or causing damage to the tissue or biopsy due to reduced cutting speed, prevents contamination of the biopsy specimen collection, and prevents obstruction of the biopsy specimen collection tubing from returning. In some embodiments, the cutting step may be used after one or more vacuum assisted biopsy procedures have been performed and may be used to sterilize certain portions of the device, tissue, wound, biological material, or any other material to reduce the possibility of infection associated with the procedure. In some embodiments, the cutting step may be used for multiple purposes, such as both to remove the patch.

[0170] In some embodiments, one or more aspects of the ablation process are selected by a user from a button, dial, other control, or a combination of these. In some embodiments, one or more aspects of the ablation process are semi-automatically or automatically controlled. These semi-automatic or automatic controls may consist of one or more sensors, timers, mechanical components, electrical components, computer components, processors, other external components, other internal components, or combinations thereof. The controlled or modulated aspects of the ablation process may include one or more types of ablation actuation, wavelength, frequency, intensity, initiation, duration, device position, location of tissue or material target, any other aspect controlled, or combinations thereof.

[0171] In some embodiments, the device has an automatic ablation process optimized for use with a particular type of patch material. These aspects of the ablation process may be controlled by the user, semi-automatically, automatically, or by a combination of these controls. In some embodiments, one or more aspects of the ablation process are controlled by attaching a particular cartridge or disposable component to another aspect of the device. For example, a portion of the cartridge containing the patch material used for kidney or liver biopsy (e.g., an external RF code or the shape or length of a particular component) may encode specific instructions for the ablation process. These instructions, when combined, can then be sensed, interpreted, and executed by other components of the device. In some embodiments, the device is actuated by the user to perform a biopsy while the patch material is set to perform occlusion, and the ablation process is optimized to break the chemical bonds of the polymerized patch material at or near the surface of one or more photon diffuser components.

[0172] In some embodiments, the device performs an ablation step after each use. In some embodiments, the device uses sensors (such as those used in conjunction with reflectance spectroscopy) or other components to measure the photocuring process, other patch curing process, photoablation process, some other process, or some combination thereof to help control one or more aspects of the ablation process.

[0173] In some embodiments, the ablation process is used in conjunction with partial or complete activation of the patch material within one or more portions of the device. Partial activation of the photopolymerized patch material within portions of the device has not been previously described for these purposes, likely due to its tendency to interfere with these components and adhere to the needle or catheter lumen walls. This ablation process clears these internal components or lumens and allows the patch material to flow with less power or contamination from debris. In order to completely close the tissue (using photopolymerized or other patch material) to high tensile strength in high bleeding situations, it also takes a long release and / or activation time, which tends to increase the amount or strength of the tissue closed to the patch material and device components. This ablation process can reduce traumatic forces to the tissue and hardened patch material by better releasing the device in these situations. In some embodiments, the use of photon ablation in conjunction with photopolymerized patch material to close biopsy-related wounds allows for the unexpected additional simplification, safety, and precise control of the above-mentioned advantages. In some embodiments, there are one or more ablation steps during the automatic retraction process.

[0174] In some embodiments, the device comprises a catheter that extends over some portion of the device after application of one or more patch materials to break at least some of the chemical bonds of the patch material. In some embodiments, the device comprises a catheter that extends over some portion of the device after application of one or more patch materials to break at least some of the physical bonds of the patch material. In some embodiments, the ablation catheter comprises a catheter with a light diffuser that can deliver light or additional instruments into the lumen of the catheter to some portion of the catheter. In some embodiments, the ablation catheter comprises a catheter with a light diffuser that only projects light into the lumen of the catheter. In some embodiments, the ablation catheter comprises a catheter that is used during some periods to deliver light to cure the photopolymerized patch material and during other periods to deliver light to break the chemical bonds in the cured patch material. The light for these different functions may be delivered from the same or different portions of the catheter and may use the same or different wavelengths. For example, the device may include a light delivery catheter that is used during a renal biopsy to deliver light from a distal end to harden the patch material at a location distal to the tip of the catheter, and then, after the needle is retracted, delivers light from a proximal location within the catheter to break down some of the chemical and / or physical bonds of the patch material to prevent interference with a subsequent biopsy procedure or contamination of the biopsy specimen.

[0175] 6. Balloon Assisted Patch Placement In some embodiments, the tissue repair device comprises an inflatable balloon within a section of the patch material. In some embodiments, the balloon is inflated to aid in evacuation of the patch material. In some embodiments, the balloon is inflated to apply pressure to a site (e.g., a biopsy site) for tissue repair. In some embodiments, the balloon is inflated to apply pressure to the patch material when applying pressure to a site for tissue repair.

[0176] In some embodiments, as shown in Figures 41A-41F, the balloon may be inflated to expel the patch material from the device. In some embodiments, the balloon applies pressure to the patch material as it is applied to the site for tissue repair. In some embodiments, after an initial amount of patch material is applied, the balloon is retracted within the device. In some embodiments, after being retracted, additional patch material is applied into the space vacated by the balloon.

[0177] In some embodiments, the balloon is filled using a fluid. The device may include a balloon fluid reservoir for containing the fluid used to fill the balloon. In some embodiments, the balloon fluid reservoir is pressurized upon actuation such that the fluid fills the balloon. In some embodiments, the device includes a valve or actuator that upon actuation places the balloon in fluid communication with the balloon fluid reservoir. In some embodiments, an outlet is in fluid communication with the reservoir. In some embodiments, venting the reservoir allows for a reduction in pressure such that the tension of the elastomeric material from which the balloon is constructed causes the balloon to retract back into the device.

[0178] In some embodiments, the balloon is made of polyurethane, silicone, another suitable elastomeric material, or a combination thereof. In some embodiments, the balloon includes a coating. In some embodiments, the coating is hydrophobic. In some embodiments, the coating is hydrophilic. In some embodiments, the coating is selected to reduce adhesion to one or more patch materials utilized in the device.

[0179] E. Optical sensor In some embodiments, the device comprises one or more optical sensors including a photodiode surface, a nanopatterned FO-SPR sensor chip, a touch imprint cytology (TIC), a charge coupled device (CCD) (which may be a silica or IR coupled device), analog (voltage or current) domain and digital (pulse count) domain, single detector, multi-detector, photomultiplier tube PMT (for spectroscopy and / or microscopy), time-gated PMT, linear CCD (and photodiode array), one or more CCDs, an "Open Electrode" (or "Open Poly") CCD, a silicon CCD, a typical front-illuminated CCD (e.g., coated with a phosphor to improve its UV response), an electron multiplying CCD (EMCCD), an intensified CCD (ICCD) detector, or a combination thereof.

[0180] In some embodiments, the optical sensor senses the environment and / or the type of surrounding biological tissue, In some embodiments, the data received by the sensor is used to automate one or more processes performed by the device or to provide feedback to a user of the device.

[0181] F. Patch Material Sensor In some embodiments, the device includes a patch material sensor, which in some embodiments comprises one, two, or more sensors including a bioimpedance sensor, an optical sensor, a pressure sensor, other sensors, other sensors, or combinations thereof.

[0182] In some embodiments, patch material sensors are used to detect the extent of polymerization while still within a portion of the device. This can be important to ensure that polymerization has occurred to the correct extent before injecting the patch material into the target area so that the patch material has the tensile strength and viscosity to withstand the pressures and turbulent forces associated with arterial pressure bleeding. Alternatively, these sensors may be used to ensure that the patch material components or mixtures have the correct composition for the intended organ or purpose. For example, in some embodiments, one, two, or more short bands of NIR spectra may be rapidly analyzed by the sensor and used to determine the concentration of water molecules relative to the solute. Other molecules may be detected in other bands of the NIR and absorbance spectroscopy tests.

[0183] 1. Patch material information display In some embodiments, the device includes information to the user providing information regarding patch material level, availability status, number of doses available, priming status, type, intended organ, strength of closure, information about mixed components, availability status of mixed components, completion of mixing, viscosity information, injection volume, low level warning, other warnings, expiration date, cure status, vacancy status, mechanism status, other information regarding patch material, or some combination thereof. In some embodiments, the patch information display of the device provides information regarding one, two, or more patch materials, substances, cells, ingredients, mixtures, additives, strength of closure, or any other components thereof.

[0184] In some embodiments, the patch material information displays the information on a digital display, an LED screen, an ultrasound-guided viewing screen, a CT-guided viewing screen, an MRI-guided viewing screen, some other electronic viewing screen, an indicator light, a physical window on the patch material, a color display, some other physical display, some other display, some other display system, or a combination thereof.

[0185] 7A-9C, a patch material information display is illustrated according to some embodiments. In some embodiments, the information display is provided on the needle cartridge. In some embodiments, the needle cartridge (750) includes a treatment display (710) that provides information regarding the type of treatment to be performed. In some embodiments, the patch material is prepared based on the treatment to be performed. In some embodiments, the needle cartridge (750) includes a gauge (720) that displays the amount of patch material remaining in the cartridge.

[0186] In some embodiments, the device includes a control (705) that houses the needle cartridge. In some embodiments, the control includes a display (715) that presents information regarding the status of the control, the status of the procedure, the status of the cartridge, or other information that may be useful in performing a biopsy and / or repair of a biological wound site.

[0187] In some embodiments, the patch material information display comprises a window for a user to physically view the patch material within one, two, or more portions of the device. In some embodiments, the patch material information display has a window for a user to physically view the patch material. In some embodiments, the patch material information display includes indications corresponding to different levels of patch material within the device, prime status, available status, available times, empty status, patch material release information, conveys information as previously described, or some combination thereof.

[0188] In some embodiments, the device includes one, two, or more patch material information displays, both physical and electronic in nature. In some embodiments, the device includes one, two, or more patch material information displays, including both a physical window for viewing the patch material components and an electronic display mechanism. In some embodiments, the device includes one, two, or more patch material information displays, including both a physical window for viewing the patch material components and an electronic-based display mechanism. Having a combination of both types of information may facilitate visual analysis, as some patch materials may polymerize, leak, be premixed, contaminated, or otherwise altered before use, and in some cases may only be detectable by a user's visual analysis. After the patch material has been jostled, pressed, moved, mixed, activated, or otherwise altered, the user may not be able to detect some information and may need to rely on other displays and sensors. In order to safely inject the patch material, particularly in uses such as hemostasis of arterial bleeding, the device may need to be provided with both a window patch material display and a digital display or indication system.

[0189] G. Instrument Cartridge In some embodiments, the device consists of a housing, a removable instrument cartridge consisting of one or more biopsy needles, a mechanism for injecting light-polymerized patch material and closing the wound, a single user control mechanism to turn both the patch delivery and curing mechanisms on or off, components and controls for standard biopsy procedures, and a light source.

[0190] In some embodiments, the device comprises a housing, a removable instrument cartridge of one or more biopsy needles, a mechanism for injection of photopolymerized patch material and wound closure, a single user control mechanism for turning both the patch delivery and curing mechanisms on or off, components and controls for standard biopsy procedures, and a light source. In some embodiments, the device comprises a housing, a removable instrument cartridge of one or more biopsy needles, one or more photon projection components for partially polymerizing patch material components within the lumen of the device before delivery to a separate target site and further polymerization, a mechanism for injection of photopolymerized patch material and wound closure, one or more user control mechanisms for turning both the patch delivery and curing mechanisms on or off, and components and controls for standard biopsy procedures. In some embodiments, the device comprises a housing, a removable instrument cartridge consisting of one or more biopsy needles, one or more photon projection components for partially polymerizing patch material components within the lumen of the device prior to delivery to a separate target site and further polymerization, mechanisms for injection of photopolymerized patch material and wound closure, components for the excision process, one or more user control mechanisms for turning the patch delivery and curing mechanisms on or off, and components and controls for standard biopsy procedures.

[0191] 10A-10E illustrate a needle cartridge (1050) and a patch material reservoir (1055). In some embodiments, the reservoir fits within the needle cartridge. In some embodiments, when the reservoir is pushed distally, the patch material is expelled from the distal end of the needle. In some embodiments, mating of the reservoir and cartridge facilitates selection of the patch material as disclosed herein.

[0192] In some embodiments, as shown in FIGS. 18A-18E, the needle cartridge (1850) may include one or more components that interface with the controller when the needle cartridge is placed in a needle cartridge recess of the controller. In some embodiments, the recess provides components for manually / mechanically translating components of the needle cartridge. Additionally, electrical components may be placed in electrical communication with corresponding electrical components of the needle cartridge when the needle cartridge is accommodated. In some embodiments, the controller may be adapted for use with multiple needle types, such as retractable telescopic needles (1821), (1823), (1825) and biopsy needles (1822), (1823). Additionally, the controller may be adapted to actuate different mechanical components provided on the needle cartridge. For example, the needle cartridge of FIG. 18C may interface with a horizontal gear actuation system of the controller, as shown in FIG. 30B.

[0193] 35 illustrates an automatic needle retraction system, according to some embodiments. In some embodiments, the retraction system includes a spring and teeth that engage the needle carrier. In some embodiments, when the needle carrier extends beyond the teeth, the spring biases the needle carrier proximally to retract the needle.

[0194] 36A and 36B illustrate a needle retraction system that includes a slider that is actuable by the user to retract the needle after use.

[0195] 37A-37B illustrate a system for automatic activation of a light source to initiate light polymerization material. In some embodiments, as the needle carrier (3705) is translated downward to release the light polymerization material, a lever (3710) abuts an edge causing the lever to rotate. The lever may then be an activation switch to activate the light source. The system may allow for timing of dispensing of the light polymerization material with activation of the light source.

[0196] In some embodiments, the device comprises a housing, a removable instrument cartridge of one or more biopsy needles, a locking mechanism to prevent repeated biopsy specimens from being taken after a single application of the patch material, a mechanism for injection of the light-polymerized patch material and closure of the wound, one or more user controls to turn the patch delivery and curing mechanism on or off, components and controls for standard biopsy procedures, and a light source. In some embodiments, the device comprises a housing, a removable instrument cartridge of one or more biopsy needles, a locking mechanism to prevent repeated biopsy specimens from being taken after a single application of the patch material, one or more photon projection components to partially polymerize patch material components within the lumen of the device before delivery to a separate target site and further polymerization, a mechanism for injection of the light-polymerized patch material and closure of the wound, one or more user controls to turn the patch delivery and curing mechanism on or off, components and controls for standard biopsy procedures, and a light source.

[0197] In some embodiments, the device comprises a housing, a removable instrument cartridge consisting of one or more biopsy needles, a locking mechanism to prevent repeated biopsy specimen collection after a limited number of applications of the patch material, one or more photon projection components for partially polymerizing patch material components within the lumen of the device before delivery to a separate target site and further polymerization such that delivery and closure can withstand bleeding pressures of up to approximately 250 mmHG per application, a mechanism for injection of photopolymerized patch material and wound closure, one or more user control mechanisms for turning the patch delivery and curing mechanisms on or off, components and controls for standard biopsy procedures, an ablation process, and a light source.

[0198] In some embodiments, the device comprises a housing, a removable instrument cartridge consisting of one or more biopsy needles, a locking mechanism to prevent repeated biopsy specimen collection after a limited number of applications of the patch material, one or more photon projection components for partially polymerizing patch material components within the lumen of the device before delivery to a separate target site and further polymerization, a user-selectable patch material cartridge according to one or more variables associated with the intended use, a mechanism for injection of the photopolymerized patch material and wound closure, one or more user control mechanisms for turning the patch delivery and curing mechanisms on or off, components and user controls for standard biopsy procedures, and a light source.

[0199] In some embodiments, the device comprises a housing, a removable instrument cartridge consisting of one or more biopsy needles, one or more attachment points for attachment to a separate image guidance system and one or more attachment points for external robotic actuator control, a locking mechanism to prevent repeated biopsy specimen collection after a limited number of applications of the patch material, a user-selectable patch material cartridge according to one or more variables related to the intended use, and a mechanism for injection of photopolymerized patch material and wound closure.

[0200] In some embodiments, the device comprises a housing, a detachable instrument cartridge consisting of one or more biopsy needles, one or more attachment points for attachment to a separate imaging-based guidance system and one or more attachment points for external robotic actuator control, a locking mechanism to prevent repeated biopsy specimen collection after a limited number of applications of the patch material, one or more photon projection components for partially polymerizing patch material components within the lumen of the device before delivery to a separate target site and further polymerization, a user-selectable patch material cartridge according to one or more variables associated with the intended use, and a mechanism for injection of photopolymerized patch material and wound closure.

[0201] In some embodiments, the instrument cartridge may include one or more patch sensors. These patch sensors may consist of bioimpedance sensors, pressure sensors, optical sensors, IR sensors, NIR sensors, UV sensors, vibration sensors, position sensors, viscosity sensors, torque sensors, bending sensors, rotation sensors, other sensors, or any combination thereof. The sensors may be used to determine many unanticipated aspects of the device and patch material, such as by monitoring component concentrations, viscosities, strengths, or other aspects of the patch material partially activated within the lumen of the device prior to injection into the instrumentation path, as an aid in ensuring hemostasis in occlusion and arterial blood pressure bleeding situations.

[0202] In some embodiments, the instrument cartridge is reusable. In some embodiments, the instrument cartridge contains the patch material components in separate chambers prior to priming. In some embodiments, the instrument cartridge comprises one or more patch material mixing chambers. In some embodiments, the instrument cartridge comprises a sterile cover. In some embodiments, the sterile cover comprises an external sterile sleeve, an internal sterile sleeve, a sterile component capsule system, a sterile sleeve trimming system, some other sterile cover, or a combination thereof. Figure 38 illustrates an exemplary sterile sleeve (3800), according to some embodiments.

[0203] In some embodiments, the instrument cartridge includes a connector to an external axial drive component that also connects the waveguide. This may be permanently or reversibly connected. In some embodiments, the instrument cartridge connects to the telescoping waveguide in a separate portion of the device. In some embodiments, the instrument cartridge includes an integrated light source with low mass. In some embodiments, the sterile sleeve passes photons from the light source for light initiation. In some embodiments, the sterile sleeve passes photons required for RF ablation. In some embodiments, the sterile sleeve includes a raised platform (3805) and a flexible top (3810).

[0204] In some embodiments, the instrument cartridge comprises a control unit. In some embodiments, the instrument cartridge comprises one or more of an external catheter, an internal catheter, a waveguide in the catheter wall, a light diffuser in the catheter wall, a light diffuser capable of activating light in the lumen of the catheter, a stretchable catheter, a stationary catheter, a retractable catheter, or any combination thereof. In some embodiments, the instrument cartridge comprises a plate capable of transmitting ultrasound, as shown in Figures 48A and 48B. The plate may comprise a connector (4805) for attachment to the housing of the device. The plate may comprise an opening (4810) through which a needle or the device can be guided.

[0205] In some embodiments, as shown in FIGS. 7A-9C, needle cartridge (750) may include one or more components that interface with controller (705) when the needle cartridge is placed within needle cartridge recess (751) of controller (705). In some embodiments, recess (751) provides components for manually / mechanically translating components of the needle cartridge. For example, button (740), when depressed, may correspond to translating actuator (745), thereby engaging actuator button (755) of the needle cartridge. Additionally, electrical component (770) may be placed in electrical communication with corresponding electrical component (775) of the needle cartridge when the needle cartridge is seated.

[0206] In some embodiments, the instrument cartridge comprises a port. The port can serve as a connection for attaching one or more syringes, vacuum tubes, luer locks, or combinations thereof. In some embodiments, the instrument cartridge can comprise a computer system. In some embodiments, the instrument cartridge has one or more patch material sensors located within that portion of the device. Similarly, a primer button (760) provided on the control may engage a primer button (765) provided on the needle cartridge.

[0207] In some embodiments, the instrument cartridge can include a vacuum system to assist in biopsy. In some embodiments, the instrument cartridge includes one or more suction attachment areas for attaching the cartridge to a biological site. Suction during closure of these biopsy wounds with a light-polymerized patch can improve the fluidity of the device's motion, so that the column of patch material is continuous and not interrupted by patient motion. This can also optimize the axial movement speed of the device's components specific to the patient's needs, organ, disease etiology, and disease severity while creating a column of patch in the wound tract. This can also allow for better assessment of bleeding before use of the patch material, thereby allowing additional biopsies to be performed before changing the cartridge. For example, the suction area can be made of a curved surface with a small enough diameter to facilitate easy introduction into the rectum while stabilizing the device to the anal tissue during a prostate biopsy. Also, suction from a curved surface during a rectal biopsy can increase stress on the tissue between the biopsy sites, maintain tissue alignment, keep the ultrasound probe and needle aligned during the biopsy procedure, and improve closure and propagation of the photopolymerized patch material by better maintaining alignment of the probe head and needle.

[0208] In some embodiments, the instrument cartridge comprises an external attachment for an RF ablation energy source. In some embodiments, the instrument cartridge comprises an external attachment for an RF ablation energy source and a light source for activation of the photopolymerized gel (see, e.g., (195) in Figures 1F and 1G). In some embodiments, the instrument cartridge comprises an external attachment for a monopolar RF ablation energy source and a light source for photopolymerized gel activation. In some embodiments, the instrument cartridge comprises an external attachment for a bipolar RF ablation energy source and a light source for photopolymerized gel activation. In some embodiments, the instrument cartridge comprises an external attachment for a monopolar RF ablation external pad and a light source for photopolymerized gel activation.

[0209] H. Light source control unit In some embodiments, the timing, wavelength, variability in wavelength, intensity, variability in intensity, amount, point of emission, point of propagation, part of the device involved, generation, part of the device generated, all intensity, intensity of a portion, shape, target, target, type of propagation, duration, interruptions along the way, target of all targets, a portion and / or other aspects or combinations thereof, relay of photons emitted from the device is timed with automatic timing by the device, manual timing by the device, semi-automatic timing by the device, timing with respect to the release of photoactive agent, timing with respect to immediate release of photons, timing with respect to delayed release of photons, timing before, during or after the procedure is completed or any combination thereof, timing before, during or after the needle is inserted or any combination thereof, timing before, during or after the tubular structure is inserted or any combination thereof, any combination thereof, or sometimes no photons are emitted at all.

[0210] In some embodiments, the extent to which the substance has undergone photochemical activation can be detected using optical input interrogating the target area, and the device may notify the user of its progress and / or make computer-based and / or computer-assisted decisions regarding the timing and / or duration of photon emission from the device. In some embodiments, emission of light from the light source is controlled relative to timing with respect to shape, structure, stenosis, internal flow, internal pressure, lumen wall pressure, bleeding, osmolality, physiology, pathophysiology, damaged, missing, removed, excised, manipulated, added, repaired, operated, and / or other features of the organ as sensed, detected, calculated, and / or presented by the user and / or computer software.

[0211] In some embodiments, the light emission from the light source is controlled to prevent deposition of the light-activated material on the device during (and / or in conjunction with) needle insertion, during (and / or in conjunction with) needle retraction, or combinations thereof. In some embodiments, the light source comprises a variation in wavelength to alter intensity, depth of penetration, or impact. In some embodiments, light is emitted from variable positions to target or avoid certain biological materials, tissues, cells, fluids, or materials, to activate certain points or locations while not activating others, to create structures, or combinations thereof.

[0212] 1. Auxiliary Sensor In some embodiments, the device comprises one or more auxiliary sensors for retrieving data related to bioimpedance of a substance, bioimpedance of an organ, bioimpedance at a biopsy cut site, bioimpedance of a needle, bioimpedance of a blood vessel, bioimpedance of a wound, bioimpedance measurements of a biocompatible patch, bioimpedance measurements of a needle portion in a target organ, bioimpedance of a portion of a substrate, and combinations thereof.

[0213] In some embodiments, the auxiliary sensor utilizes diffuse reflectance spectroscopy and / or infrared (IR) thermography to analyze the surrounding environment / tissue. In some embodiments, the sensor monitors the deposition and / or curing of the biocompatible patch material in real time. In some embodiments, the condition of the biocompatible patch material is monitored by Fourier transform infrared (FTIR) spectroscopy, x-ray diffraction analysis, bioimpedance testing, visible spectrum spectroscopy, other spectroscopic testing, and combinations thereof.

[0214] In some embodiments, the auxiliary sensors can obtain position data of the device to locate, label, and store information such as biopsy site location and number of biopsy locations for future reference. In some embodiments, the position sensor / inertial sensor includes an accelerometer, a gyroscope, and combinations thereof.

[0215] In some embodiments, hybrid nanostructured films containing graphene nanoplatelets (GNPs) and / or double-stranded DNA are utilized to detect in situ, real-time, UV radiation damaging effects through changes in the electrical properties of the films induced by exposure to UV-C radiation.

[0216] In some embodiments, the auxiliary sensors are utilized to perform one or more of the following actions: verifying placement of the biocompatible patch material; verifying proper location of the biopsy site; detecting the angle, orientation, and / or depth of the needle instrument within the tissue; detecting which portion of the needle is in which tissue, aspect of the tissue, or associated structure; analyzing the tissue for disease and / or diagnosing disease; analyzing the tissue for the presence and / or type of a second disease, a third disease, etc.; testing for cell type and health and / or disease state; testing for extracellular material.

[0217] J.Heat source In some embodiments, the device includes a heat source. In some embodiments, the heat source includes a thermoelectric or Peltier element to provide a heating and / or cooling effect. In some embodiments, the heat source is used to cauterize tissue. In some embodiments, the heat source is used to increase adhesion of the device or sealant to other parts. In some embodiments, the heat source is used to decrease adhesion of the device or sealant to other parts. In some embodiments, the heat source is used to increase or decrease the amount or rate of a sealant, stent, or substance released from the device. In some embodiments, the heat source adjusts the temperature of a photosensitive gel that requires a different temperature to maintain its shape.

[0218] In some embodiments, there is an electrosurgical control. The electrosurgical control can control the circuit aspects of the device. In some embodiments, the electrosurgical control receives information from one or more sensors as described herein. In some embodiments, the electrosurgical control activates and deactivates components of the device. In some embodiments, the electrosurgical control regulates the power supplied to the light source, heat source, cauterization components, and other electrical components of the device described herein.

[0219] III. Types of morphology Components of the tissue repair device as disclosed herein may be incorporated into various medical / surgical tools or instruments, allowing such instruments to be utilized as tissue repair devices while also performing their intended functions. In some embodiments, components of the tissue repair device may be incorporated into vacuum biopsy needles, multiple vacuum biopsy devices, core biopsy needles, fine needle biopsy devices, high speed needles, rotary biopsy needles, aspiration biopsy devices, cellular biopsy devices, pneumatic pulse activated biopsy devices, injection needles, single handed biopsy devices, double handed biopsy devices, modular biopsy systems, disposable biopsy systems, and multiple cocking biopsy devices.

[0220] A. Light Rod In some embodiments, there is a portion of the device that can extend beyond the distal end of the needle, as shown in Figures 4A-4D. In some embodiments, this provides an unexpected advantage as a larger portion of the biopsy bed can be covered and closed with patch material compared to photons projected only from the distal end of the needle or from some portion within the side of the needle. This also provides the advantage of a more uniform closure of the biopsy tract and / or biopsy tissue bed depending on the location of the projected light. This portion of the device also provides the unexpected advantage of reducing manufacturing costs and / or difficulty. Another advantage to this is that a scaffold or sheath can be advanced at the same time. This scaffold may be used to close the tissue, stabilize the patch material, or apply radial and / or distal external pressure to the surrounding tissue.

[0221] In some embodiments, the first step is illustrated in Figure 4A. In some embodiments, all components are in their initial positions. The components include the outer sheath (450), the biopsy core needle (430), the mid-rod sheath (440), and the inner light rod (410). The core needle, the mid-rod sheath, and the inner light rod are aligned at their distal ends, and the outer sheath completely covers the biopsy trough of the biopsy core needle.

[0222] In some embodiments, the second step is illustrated in FIG. 4B. In some embodiments, once the initial assembly is aligned proximate to the desired biopsy target, a biopsy action is actuated by the user. This action causes the biopsy core needle, the middle rod sheath, and the inner optical rod to be pushed forward firmly while the outer cutting sheath remains in place. Once the middle rod sheath is fully extended, it is then pulled back within the lumen of the biopsy core needle. As it is retracted, the photon-activated patch material is released into a new space within the central lumen of the biopsy core needle. The inner optical rod may or may not begin to activate the patch material surrounding the rod within the central lumen of the biopsy core needle.

[0223] In some embodiments, the third step is illustrated in Figure 4C. In some embodiments, the outer cutting sheath is advanced distally in axial alignment with the inner core needle, and the target tissue is excised and contained within the biopsy trough of the biopsy core needle.

[0224] In some embodiments, the fourth step is illustrated in FIG. 4D. In some embodiments, the outer cutting sheath, the biopsy core needle, and the middle rod sheath are retracted some distance into the tissue, maintaining the same positional relationship relative to each other. The inner optical rod is simultaneously advanced relative to the inner optical rod with little or no linear movement of the inner optical rod relative to its location in the tissue. This fully exposes the optical rod to the tissue bed from which the biopsy was excised, but does not penetrate further into that tissue. This also prevents the light delivery components of the device from unintentionally penetrating into tissue distal to tissue already penetrated by the core needle itself and / or any other portion of the needle. In some embodiments, the inner optical rod can both project photons and deliver patch material. Portions of gel already partially activated may be emitted axially distal to the biopsy tissue, or may be emitted distal to the biopsy tissue located at or around or proximal to the location. The partially activated material may act as an anchor for more patch material, as a scaffold to stabilize the location of the patch material, or may not be present at all. More gel is forced into the puncture path and the light is activated. In some embodiments, there is a shape of the inner optical rod that does not have sharp edges. In some embodiments, the edges and / or tip are rounded, elliptical, semicircular, or shaped to reduce the possibility of damage to distal or surrounding tissue. In some embodiments, the radial distance between the inner optical rod and the biopsy tissue bed is greater than the tissue in one or more of the other radial directions. This is an advantage since more patch material can be placed between the optical rod and the biopsy tissue bed. In some embodiments, there is a smaller radial distance between the optical rod and the biopsy tissue bed compared to one or more of the other directions. This is an advantage under some circumstances since the inner optical rod is closer to the biopsy tissue bed.

[0225] In some embodiments, a fifth step is illustrated in Figure 4E. In some embodiments, the middle rod sheath is then advanced distally within the central lumen of the biopsy core needle. In some embodiments, this pushes the patch material from the biopsy core needle.

[0226] In some embodiments, the inner optical rod is then retracted into the intermediate core needle. In some embodiments, this action pushes the patch material from the inner optical rod. In some embodiments, the inner lumen of the biopsy needle and / or the intermediate rod sheath has an inner radial shape similar to the outer radial shape of the inner optical rod. In some embodiments, this is an advantage as it allows the patch material to be more effectively released from the outer surface of the inner optical rod.

[0227] In some embodiments, the area around all or a portion of the inner optical rod may be filled with patch material while the optical rod is located within the central lumen of the biopsy core needle. In some embodiments, all or a portion of this material may be partially or fully activated before being released from the distal end of the needle. In some embodiments, it may act as a plug to prevent excessive bleeding or to further allow portions of activated or non-activated material to be carried away from the site of the biopsy puncture path and / or biopsy tissue bed. This provides the unexpected benefit of preventing embolization of the patch material and / or preventing the patch material from damaging tissue, cells, or physiological functions away from the target. This may help prevent portions of the patch material from damaging the renal tubules or lodge in some other part of the GU pathway. It may serve a similar function in the liver, preventing the patch material from embolizing within the organ and / or migrating to a point in the bile duct where it may cause cholecystitis or bile duct obstruction.

[0228] In some embodiments, the inner light rod sections are not all activated at the same time, such that only a portion of the photons are projected in a controlled manner. In some embodiments, only a portion of the inner light rod operates within the lumen of the inner biopsy needle. This may prevent the photons from damaging cellular structures and / or DNA.

[0229] IV. Cauterization of the biopsy site In some embodiments, a portion of the device is configured to include a tissue alteration component, such as ablation, other tissue alteration mechanisms. The ablation or tissue alteration performed before, during, or after a biopsy (or other measurement) may include electrical ablation, thermal ablation (including high and low temperature ablation), ultrasonic vibration ablation, chemical ablation, other types of tissue alteration mechanisms, or combinations thereof.

[0230] A. Tissue denaturation by RF electrosurgery In some embodiments where the device utilizes radio frequency electrosurgery, increasing the temperature of the target tissue to be modified by RF electrosurgery results in a target tissue temperature of about 60° C. to about 100° C. In some embodiments, the device facilitates hemostasis in high pressure bleeding and blood vessels in the hypertensive range (greater than 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300 mm HG). In some embodiments, these effects can produce hemostasis in diseased tissues with abnormal innate or extrinsic clotting factors or function, diseased tissues with abnormal platelet function or quantity or concentration, injured or degenerated blood vessels, degenerated or diseased tissues with poor compressibility, and / or in the presence or absence of other factors that increase the likelihood of severe bleeding. This method may be applied during hemostasis by itself, during hemostasis during a biopsy procedure, in combination with the placement of a patch material, in combination with a photopolymerized patch material, and / or in combination with other hemostatic treatments, substances, or materials. At this temperature range, mechanical and chemical bonds within the molecules are broken and / or denatured to form a homogenous coagulate. Treatment at these temperatures significantly reduces the number, density, mechanical bonds, and / or chemicals present in the tissue, cells, extracellular matrix, molecules, and / or substances. This may facilitate the binding of the biocompatible patch material.

[0231] In some embodiments, RF electrosurgery, ultrasonic cauterization, resistive cauterization, chemical cauterization, or other mechanisms may be used without patch materials to reduce the risk of bleeding associated with the use of biopsy or other instrumentation. In some embodiments, the user may prefer to denature or cauterize only the tissue bed flanking the path where the biopsy is cut. In some embodiments, this can be accomplished using very small bipolar cauterization surfaces with adjacent blades to optimize tissue denature while minimizing overheating and prevent hemostasis. This can be accomplished through rapid measurements and precise control. These measurements may be sensed between cuts and may be used for all or part of the biopsy cutting process. This technique may include internally rotating components of the device body, needle, other components, or combinations thereof.

[0232] Besides the drying and dehydration effects, the molecular and material changes of tissues, cells, substances, and molecules that are modified by RF electrosurgery and heated to these temperatures create stronger attachment sites for various types of patch materials, especially attachment to photopolymerized gels. Hemostasis can also be greatly improved by using patch materials in contact with these tissues, molecules, and substances after treatment at these temperatures. This occurs through a combination of an increased variety and density of mechanical and molecular bonds, which can better withstand stress. In some embodiments, besides modifying tissues at these temperature ranges using RF electrosurgery, closing the tissue with patch materials can improve the self-repairing properties of the tissue and / or patch materials. The improved adhesion can be facilitated by an improved tissue molecular surface, a reduced water concentration, or some other mechanism.

[0233] Because it can take up to 6 seconds for cells to be denatured by RF electrosurgery at 60°C, in some embodiments the temperature of the target cells and / or tissue is 70°C, 75°C, 80°C, 85°C, 90°C, or 95°C, so that desiccation, molecular changes, and / or denaturing effects can occur at increased rates without causing evaporation or gas expansion.

[0234] In some embodiments, the biopsy or other surgical device may be physically or wirelessly connected to an electrosurgical control, also known as a Bowie unit or electrosurgical unit (ESU). In some embodiments, this unit can detect, control, modify, activate, and stop the RF electrosurgical operation of the device. In some embodiments, the ESU has components and signals that actively detect, measure, receive, calculate, transmit, regulate, or otherwise use bioimpedance measurements of living tissue where modification to a target tissue is planned, modified, or modified has been completed. In some embodiments, the ESU uses impedance detection to modify the intensity, location, wavelength, frequency, activation waveform, measurements of other parts or operations of the device. In some embodiments, the ESU uses this input, data, and calculations to optimize and / or control the output of the device so that tissue modification, type, location, extent, or severity of molecular modification, type or concentration of desired molecular modification, water content, temperature, desiccation, cauterization, or other effects can be controlled.

[0235] In some embodiments, the use of RF electrosurgery increases the amount, number, density, shape, mechanical and / or chemical bonds of molecules or substances in the target tissue in a manner that increases adhesion to the patch material. In some embodiments, these include increasing the number or density of hydrophobic amino acids available for binding to the patch material. These may include one or more of the following amino acids: alanine (Ala), valine (Val), glycine (Gly), proline (Pro), phenylalanine (Phe), methionine (Met), and tryptophan (Trp), isoleucine (Ile), and leucine (Leu). In some embodiments, treatment of tissues, cells, and / or extracellular matrix with electrosurgery RF increases the strength of mechanical and / or chemical bonds between these structures and the patch material. In some embodiments of the device, tissues, cells, and molecules are treated with RF.

[0236] Above 200F can cause charring, resulting in increased tissue damage. In some embodiments, bipolar electrocautery facilitates sensing of temperature and impedance of the specific tissue that is modified by RF electrosurgery. This is important for use with photopolymerizing patch materials (or other types of occlusive patch materials) because it allows for better control of drying / coagulation of very thin areas. It is better to use bipolar RF electrosurgery because the patch material reinforces the cauterized edges of the biopsy site and / or pathway.

[0237] In some embodiments, the frequency and type of RF electrosurgery for use in biopsy, hemostasis, and procedures associated with the device may be high voltage discharge, mixed type, and / or coagulation type, depending on the particular procedure, location, and type of electrode used, as well as other factors dictated by the particular needs of the patient. A mixed cycle may be utilized, which allows for faster operation than a pure cauterization mode. This is important to prevent mechanical damage to tissue in contact with or adjacent to the needle and / or other parts of the device. Ideally, once the biopsy excision operation is actuated, any prevention of hemostasis may occur in less than 5 seconds, and even more preferably in less than 3 and / or 1 second. This speed is also important to the user, as a slower procedure would prevent the user from performing other important activities. In some cases, a mixed model RF electrosurgery wave may act faster than a pure coagulation model wave, but still be able to adequately desiccate and modify the target tissue, and prevent high pressure vessels, turbulence, and even bleeding from diseased tissue (even when the patient's normal coagulation system has been modified by medication or disease). It also optimizes tissue at the molecular level for closed and adherent polymerized and photopolymerized patch materials by drying and denaturing proteins without creating steam or rupturing cells. In some cases, this wave mode may be preferred if there is a need for a higher level of adhesion to a particular patch material. These mixed RF mode waves may be modulated (intermittent) waves, may be continuous, may have low to high duty cycles, may include low to high voltages, and % low to 100% duty cycles (which is the percentage of voltage over time that exists over the duration of operation).

[0238] In some embodiments, the RF electrosurgery wave mode may be a pure coagulation mode. These waves usually have a lower duty cycle time than pure "cut" mode or "mixed mode" type RF. These waves are usually higher voltage but shorter duration intermittent discharges than other types. Also, these waves take longer to complete the operation. This type of wave may be preferred for certain types of disease, tissue conditions, coagulation problems, electrode types, and / or patch material types. In some cases, this may be the preferred wave mode type if there is a need for a higher level of adhesion to certain patch materials. For example, patients with kidney disease requiring kidney biopsy are often given anticoagulant drugs for heart disease and arrhythmias and / or related problems such as DVT or Pes. When these drugs are reversed, the reversal is often not fully reversed (FFP is a blood product given to reverse the use of warfarin, but the INR only reaches 1.4 at best when the INR is normally 1 and 2 when fully anticoagulated). Patients with liver disease requiring liver biopsy often have clotting problems as well, because the liver does not always synthesize sufficient amounts and / or the right ratios of clotting factors. Some, if not most, patients in each of these groups may benefit from a coagulation-type mode as opposed to a mixed and block mode, as the benefits of better closure of tissue, better attachment of tissue molecules to other tissue molecules, better attachment to certain patch materials, less reliance on the normal coagulation system yet still being able to close high pressure vessels may greatly outweigh the risks associated with longer procedures in this setting.

[0239] In other types of embodiments, the wave mode may be a pure "cut" mode. These modes typically have a continuous low voltage wave with little variation in wave size or shape. This wave mode may be beneficial when a tumor has been identified as cancerous or removal of an area of ​​tissue is desired before, during, and / or after a biopsy procedure. This type of RF wave mode may be particularly useful in breast tissue biopsy of other tissues during tumor biopsy. This type of waveform may best be used in biopsy systems that include suction so that the tissue is not damaged during the procedure.

[0240] In some embodiments, there is a set of RF electrosurgical energy pulse types and usage types, while in other embodiments, the pulse types and energy types may be tailored to the particular organ, tissue type, disease severity, challenges associated with dosing, the need for a particular type of adhesion to the patch material, and / or other factors.

[0241] Tissue that has been desiccated and / or cauterized by RF is relatively inflexible compared to normal tissue, making photopolymerized patch materials ideal when used in combination with RF electrosurgery. When exposed to significantly swollen areas, pressure and shear forces tend to crack and break closed areas of tissue, pulling apart continuous areas of tissue treated by RF electrosurgery. This can disrupt hemostasis, tissue separation, continuity of closure, or expose areas of closed vessels, tissue, or material. This is especially true when swelling occurs within cylindrical, arched, and / or spaced tissue areas being treated by RF electrosurgery. Because photopolymerized patch materials do not rely on swelling to create pressure on the surrounding tissue to achieve hemostasis, the swelling ratio is typically much smaller than that used with other types of hemostatic materials currently in use, such as gelfoam.

[0242] In monopolar, dispersive (inactive) electrodes are needed to cover a large area. Active electrodes with small tips are usually used for cutting (points, hooks, narrow tips, sharp edges). Active electrodes with wide surfaces are used for desiccation and coagulation as well as hemostasis. In some embodiments, split pads may be used that are dispersive electrodes as monopolar RF electrosurgery is split into two, and the impedance measured at both dispersive electrodes should match, if not, the device will shut off as one of the dispersive pads may be loose and may cause thermal damage.

[0243] Two types of heating are performed using RF, where the electromagnetic energy causes the anionic and cationic molecules in the cells to move towards different poles, which are converted into kinetic energy, and then converted into thermal energy by friction. Electrical resistance is not as important. In some embodiments, the strength of the closed tissue may allow the next needle and / or biopsy to be inserted in the same plane. If there are overlapping biopsy cutting axes in the same plane, the new closure will overlap the previous closure, so it will not interfere with the effectiveness of the closure. Instead of softening the closure, the polymerizing hydrogel may actually strengthen the closure, as it polymerizes and closes the previously cauterized tissue or polymerized patch material.

[0244] In some embodiments, the biopsy device uses a mechanical blade to cut the biopsy tissue from the tissue bed in addition to bipolar RF desiccation and coagulation. The use of a mechanical cutting action in addition to bipolar RF can be beneficial because the precise sensing of temperature and / or impedance measurements of the bipolar RF system can consistently close the vessel, followed by a mechanical cut that is less damaging to the biopsy tissue bed and / or biopsy specimen as opposed to electrocautery used in cutting mode or some other type of cutting system.

[0245] In some embodiments, the active electrode of the bipolar RF electrosurgery is the blade itself, which is used for both drying and denaturing proteins of the tissue of the biopsy specimen that connects to the biopsied tissue bed. This may allow for preventing high pressure bleeding from occurring in the biopsy tissue bed. In some cases, the other bipolar electrode is the second blade. In some embodiments, the first bipolar blade is part of the outer cutting needle and the second bipolar blade is part of the core needle. This significantly simplifies the construction of the device in an unexpected way and incorporates prevention of arterial pressure bleeding without significantly changing the movement and operation of the device. This also allows for preventing thermal damage to the biopsy tissue and / or mechanical damage to the biopsy tissue and / or tissue bed during the desiccation, coagulation, and / or protein denaturation of the RF electrosurgery. This also has the unexpected advantage of minimizing the amount of tissue denatured by RF electrosurgery (if RF electrosurgery is the only type of hemostasis used) while still providing a tissue closure capable of withstanding arterial levels of hydrostatic pressure generated by the denatured bonds and new bonds formed within the tissue itself.

[0246] In some embodiments, the device uses the edge of the blade that cuts and frees the biopsy specimen to act as the active electrode surface, and the bipolar RF electrosurgery desiccates, coagulates, and / or denatures proteins along with the use of photopolymerized hydrogels and / or RF electrosurgery-denatured tissue bed attachment at some portion of the puncture path. This provides the unexpected advantage of reinforcing tissue bed denatured proteins. In some embodiments, this allows the amount of tissue denatured by RF electrosurgery closure to be minimized. First, the use of electrodes at the edge of the biopsy blade minimizes the width of tissue exposed to the current. This may also allow for precise sensing of the tissue to cut and free the biopsy specimen. The patch material also reinforces the biopsy tissue bed, minimizing the extent of tissue denaturation.

[0247] In some embodiments, the device may use RF electrosurgery with selectively one, two or more electrodes on the cutting edge, and may use RF electrosurgery frequencies of the coagulation type and / or mixed frequency variety. These frequencies are preferably modulated (intermittent) waveforms that are coagulation type frequencies. Mixed may include frequencies that are modulated low voltage waveforms, and typically have a wider duty cycle on the ESU than pure coagulation conditions. This also allows for precise alignment of mechanical action with the area monitored by impedance and / or thermal measurements to separate tissue or biopsy specimen from the biopsy tissue bed mechanically rather than by thermal means. Use of these frequencies as opposed to "cut-off frequencies" reduces the likelihood and magnitude of tissue degeneration; reduces the amount of thermal tissue damage; reduces the likelihood of mechanical damage to the tissue and specimen due to cell rupture and rapid expansion of gas; reduces the likelihood of mechanical and / or thermal degeneration of the biopsy specimen which may compromise the utility and readability of the specimen; increases the likelihood that the closed tissue will withstand arterial pressure hydrostatic forces and turbulent bleeding; and creates a surface with more binding sites and stronger attachment to the patch material.

[0248] In most types of biopsies, the tissue from which the biopsy specimen is excised may cause the majority of the hemorrhage. The use of a patch material at the axis of the biopsy puncture path in addition to RF electrosurgery to specifically close the biopsied tissue bed has the unexpected advantage of selectively closing the biopsied tissue bed with the strongest bond with the patch material while flexibly closing other areas of the puncture path. Tissue modified by RF electrosurgery, among other things, has more mechanical bonds, a drier surface, more hydrophobic molecules exposed to the outside world, more proteins modified to allow for tissue penetration and entanglement, and more hydrogen bond sites. The modified tissue bed also provides more chemical bonds and fewer water molecules to interfere with the chemical bonds. The tissue also provides stronger mechanical forces and more available low energy bonds that can be formed spontaneously, allowing better self-repair by the patch material that is bonded to the modified tissue bed. Although the patch material bonds less strongly to other parts of the puncture path, it still provides similarly strong hemostasis in the unmodified areas of the puncture path in some embodiments. Therefore, even if there is tissue movement or force affecting the tissue tract strong enough to disrupt closure of the patch material from one portion of the tissue in the biopsy puncture path, it is much less likely to disrupt closure of the biopsied tissue bed (where the majority of the heavy bleeding occurs).

[0249] In some embodiments, the biopsy device uses a combination of bipolar RF and laser cutting systems. Bipolar RF can precisely desiccate and modify tissue and can be very advantageous when combined with a laser. The device can precisely determine if tissue in contact with the device is ready to be cut with the laser. Use of the laser can be continuous, pulsed, or intermittent. However, because impedance and temperature can be precisely measured, use of the laser can be optimized to prevent overheating that may damage the tissue biopsy tract, the biopsy tissue bed, and / or the biopsy tissue specimen. When both are used, there is a high risk of overheating the tissue, but precise control allows them to be used safely together. RF also has the advantage of better control over the degree of tissue modification, which can be used to minimize thermal damage to the biopsy tissue.

[0250] Another unexpected benefit of denaturing tissue before injecting patch material, especially when using photopolymerized materials, is that it alters and reduces the electrostatic forces of the tissue that is denatured during the procedure. Only some experts in performing surgery or performing biopsies are aware that the electrostatic charge of normal tissue is harmful and that it is naturally electrostatically repelled by most types of photopolymerized molecules, monomers, and polymers. In fact, there is only one monomer, chitosan, that has a positive charge. If only photopolymerized patch material is used, chitosan will be electrostatically attracted to the tissue. This is because animal cell walls are typically phospholipids that have a negative charge. When these cells are destroyed as the molecules are denatured and dehydrated during RF electrosurgery (and other types of heating), the negative charge of the tissue becomes more favorable, and most other types of patch materials, especially photopolymerized patch materials, mechanically attach much better to the tissue before and after polymerization.

[0251] The "off mode" waveform mode provides better coagulation for hemostasis. It is a low voltage continuous or discontinuous waveform that prevents higher temperatures from building up in the tissue, yet can be used to measure the impedance of the biomaterial between the electrodes exposed to the tissue.

[0252] In some embodiments, monopolar electrodes may be used alone or in combination with patch materials. In some embodiments, the patch material is a plug or mesh. In some embodiments, the patch material is a photopolymerizing material. In some embodiments, the patch material used in combination with the needle does not require photons to form a polymer. In some embodiments, all or a portion of both the core needle and the outer needle are used as active electrodes in a monopolar device with the patch material. This may, in some embodiments, result in a more consistent amount of tissue change throughout the area exposed to the active electrode than other types of electrosurgery, thermal cauterization, or acoustic cauterization. This in turn increases the likelihood that the patch material will adhere consistently to these areas, especially when used in combination with photopolymerizing patch materials. This is because other types of electrosurgery and cauterization may have difficulty achieving consistent results due to vasculature, nerve, tissue or vasculature variations, fluid variations, electrolyte variations, and / or any other variable that may affect tissue changes that are more variable than monopolar RF. For example, when using a bipolar mode of RF electrosurgery where only the two cutting edges of the biopsy needle serve as the two active electrodes, the tissue and / or material between these two portions may include the interior of a blood vessel that has a lower impedance than the other portions of the material between the electrodes. This may result in an uneven cauterization effect during operation of the RF electrosurgery, whereby some portions of the activated area are not optimally denatured (the percentage of water removal and / or the percentage of denatured molecules may vary significantly between portions of the tissue). These differences may also cause the patch material to form at different rates, thereby further increasing the chance of bleeding and complications from the procedure. Because the non-active portion of the electrode is so far away from the monopolar active electrode, the affected tissue has an unexpected constancy with respect to the variability that increases the rate and strength of attachment formed between the patch material and the tissue or material, among other things.

[0253] In some embodiments, a portion of the core needle in a monopolar system acts as an active electrode, activating and denaturing tissue at one, two or more of the following locations: .5 cm, 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5 cm, 7 cm, 7.5 cm from the distal end of the needle, most distal. In some embodiments, one, two or more portions of the external cutting needle in a monopolar RF electrosurgical ablation system act as the active electrode. In some embodiments, the active electrode is the portion of the inserted component that only contacts tissue and / or is only active during one, two or more periods of time the device is in the body. In some embodiments, the monopolar active electrode includes portions of both the core needle and the cutting needle, the needle or another portion of the device. In some embodiments, a portion of the needle, a distal portion of the core needle, and a distal portion of the cutting outer needle may be the same or different areas that are used for the biopsy and exposed to the biomaterial. In some embodiments, the amount of needle exposed is the periphery of all or a portion of the needle. In some embodiments, only a portion of the cutting outer needle or some other portion of the device functions as the active electrode.

[0254] In some embodiments, the non-active electrodes used in RF electrosurgery include only one electrode to distribute the charge. Because the size of the area in electrical contact with the electrode and the patient is relatively large, the temperature of the tissue, cells, and materials near the electrode does not increase significantly during the procedure. In other embodiments, there are multiple electrodes used to distribute the charge of the non-active electrodes. In these embodiments, two, three, or more non-active electrodes are separately attached to the ESU, so that the ESU can detect the variation in bioimpedance between the different non-active electrodes and detect the area reduction of any part related to the area of ​​the patient, which may be an area small enough to heat the tissue, material, or material. In some embodiments of the device, there is a thermal barrier surrounding all or part of the tissue to be biopsied, the patch material, the wire, the photon propagation portion of the device, or the area around the photon projection portion of the device.

[0255] Another unexpected benefit of using a combination of RF radiosurgery to dehydrate, cauterize, vaporize, or otherwise modify tissue and patch material is that it prevents the patch material from embolizing blood vessels or embolizing through blood vessels to unintended locations in the patient, such as blood vessels, tissues, or organs adjacent, proximate, or relatively distant from the intended site of use. This is particularly true in biopsy procedures where the patch material may be unexpectedly exposed to turbulent, venous, capillary, arterial, luminal, high pressure, anticoagulation, arteriovenous malformation, or other types of dangerous blood flow. The blood flow where embolization of the patch material occurs may not be visible due to limitations of imaging devices such as x-rays, CT scans, MRIs, and ultrasounds. For example, the diameter of these blood vessels where embolization of the patch material may occur may be significantly smaller than 1 cm. This is the standard width of an ultrasound probe beam, and blood vessels smaller than this size may not be detected or properly displayed by imaging devices, preventing users of biopsy, endoscopy, bronchoscopy, or other devices from accidentally plugging or destroying the structures in question before releasing the patch material. Imaging devices have a variety of similar limitations, including, for example, difficulty in identifying, locating, or differentiating between vascular structures and structures in the brain with the blood-brain barrier, small blood vessels in the lungs, vascular malformations and small caliber high pressure vessels in the kidneys, milk ducts in breast tissue, small arteries in the prostate, gastric and esophageal varices during endoscopy, challenges with tissue layer differentiation, and a variety of other issues related to imaging quality that increase the likelihood of embolization of the patch material.

[0256] In some embodiments of the device, the use of RF electrosurgery before, during, or after the use of patch material or hemostatic agents significantly reduces the risk of embolization of these materials. When used in combination, the patch material is less exposed and may reduce the possibility of embolization occurring in various types of blood flow, such as normal blood flow, turbulent flow, venous, capillary, arterial, luminal, extraluminal, high pressure, anticoagulant, or other types of dangerous blood flow. This can prevent embolization of the patch material caused by the limitations of imaging in various types of tissue. This can allow the use of types of patch materials that would otherwise be prohibited. This can even make currently used patch materials safer and more effective.

[0257] This effect of RF electrosurgery in preventing embolization of the patch material is particularly true when certain portions of the puncture path are cauterized during some procedures, such as the portion of the puncture path where the biopsy specimen is cut or otherwise removed from the tissue. Cauterizing the tissue at the extent or location of the biopsy can greatly reduce the risk of embolization of the patch material. For example, a standard Tru-Cut type biopsy needle cuts a biopsy specimen from the tissue bed approximately 1 cm proximal to the distal end of the needle. The biopsy specimen section is approximately 1.5-2 cm in length. The use of RF electrosurgery to reduce bleeding over all or a portion of these regions is particularly useful in reducing the likelihood of embolization of the patch material. In some embodiments, only a portion, half, a quarter, or multiple sections of the tissue are modified by RF electrosurgery in combination with the use of a patch, reducing the likelihood of embolization while reducing the area damaged or modified. Compartmentalizing this area can be particularly important in diseased tissues that cannot properly regenerate, such as tissues in the spine or brain, kidney, lung, eye, or other organs or parts of organs. The reduction in the amount of embolization of patch material by the use of some embodiments provides the unexpected benefit of having much more precise control over the amount of patch material at the intended site. This is particularly important when the patch material needs to prevent bleeding from high pressure blood vessels, but the expansion of the hydrogel can cause adjacent ischemia. This is true for certain organs, such as the kidney or brain. For example, if there is even a small amount of bleeding in the brain cortex adjacent to the procedure, there is often an area called the penumbra of ischemic or infarcted tissue that appears as a thin shadow that develops around and surrounds the bleeding area. Having too much patch material in that area of ​​brain tissue can also cause excess pressure, especially if the material is hydrophilic. Preventing embolization of patch material by the combination of RF electrosurgery and patch material is also important in precisely controlling the amount of patch material at the target site.

[0258] In some embodiments, the use of RF electrosurgery in combination with photopolymerizing patch material has the advantage of further reducing the possibility of problems associated with embolization to an unexpected degree. Although photopolymerizing patch material only reaches an excited energy state when exposed to light of a certain wavelength and intensity, turbulent flow and high wetness conditions often cause photopolymerization to occur selectively away from the lumen of the tissue bed or puncture path. However, with reduced blood and fluid flow, a high percentage of patch material monomers can come into contact with and bind to the tissue wall as the molecules are denatured, greatly increasing the rate at which photopolymerization occurs in the wall of the tissue bed or the lumen of the path, further reducing the possibility of embolization. Also, photons may be preferentially used to target the wall, which would not be possible if photons were not used, as it would require building the polymer from the center of the lumen toward the tissue and essentially pushing any bleeding to polymerize. In some embodiments, the combination of RF electrosurgery and the photopolymerized patch material therefor prevents loss of monomers and unbound polymers of the patch material through embolization, and combined with the low swelling ratio of the photopolymerized gel allows for a very precise amount of patch to be used, preventing multiple problems when used in sensitive tissues such as the cortex of the brain. This improved safety also provides additional protection in the use of photopolymerized hydrogels in patients with high blood pressure, abnormal or diseased tissue, or clotting problems.

[0259] In some embodiments, RF electrosurgery used to dehydrate and denature tissues reduces the embolization potential of non-photopolymerized patch materials to an unexpected degree. Reduced bleeding, reduced turbulence, reduced wettability, and reduced hydrostatic pressure increase the rate of mechanical and chemical attachment to target tissues and materials, allowing for specific targeting and polymerization of the interface of the side walls of tissue tracts or biopsy beds without the need to build polymer from a central axis toward those tissues to build pressure to resist bleeding. This also allows for the formation of three-dimensional structures of bonds and polymerization, allowing for better prevention of embolization during repair and molecular reorganization even one, two, or more days after placement. This also increases the attachment strength and burst pressure, as well as the rate at which these properties increase. These materials rely on photons of specific wavelengths and intensities for activation, making them much less likely to cause problems if embolization does occur.

[0260] In some embodiments of the device, the patch material is fully activated by heat generated by the device. In some embodiments, the heat activating all or a portion of the patch material is from the heat of the device, the needle, the cartridge, or some other aspect of the device. In some devices, there is a control to select activation of the patch material by heat. In some embodiments, this control of activation is automatic. In some embodiments, activation occurs secondary to a semi-automatic process, a sensor, or other method.

[0261] In some embodiments, tissue modification by RF electrosurgery is performed with one, two, or more portions of the inserted aspects of the device functioning as active electrodes, which are separated into one, two, or more portions of the inserted device that are part of the active electrodes and do not conduct electricity to the tissue, material, or substance. This may be accomplished using a physical barrier that cannot conduct. This may be a portion of the device that conducts electrons much more slowly, a portion of the device that has high resistance or impedance, or a portion of the device that is spaced apart from other aspects of the device and / or tissue, material, or substance so that it does not transmit electrons anywhere else. In some embodiments, these regions may be modified or altered. In some embodiments, the user may select which mode they want to use for the entire treatment and / or for parts of the treatment.

[0262] In some embodiments, RF electrosurgically modified, acoustically, thermally modified, cauterized, or otherwise modified tissues, when used with polymers, skip unmodified tissue segments in one, two, or more planes to break the continuous segments of tissue. These tissues have high burst pressure and overall strength, but low elasticity, increasing the likelihood of fracturing under shear or torsional forces. Such fracturing may cause immediate or delayed bleeding or loss of closure. Also, the fracturing segments may no longer be able to withstand axial stretching or compression, and may even open and damage the underlying tissue. When skipping segments is used with patch materials, more elastic patch materials may be flexible under shear and torsional forces, preventing fracturing of the modified or cauterized tissue while maintaining high burst pressures that significantly exceed those of 140 mmHG, 200 mmHG, or higher blood pressure rises. This also allows compression and stretching of these segments, greatly reducing the likelihood of the tissue opening under these forces. This combination of structures also increases the self-repairing ability of the patch material. For example, when used with renal biopsy, horizontal skip junctions may be placed between the vertical parts of the degenerated sealing tissue relative to the axis of the puncture path. In this way, there are different parts of the kidney tissue that may themselves have different elastic moduli, and therefore the body's movements may cause lateral or shear forces in only a small part of the closed path. This may damage a portion of the patch material, because it allows flexibility with the movement, but concentrates the movement in the skipped section, especially the patch material on the side where the stretching force occurs as opposed to compression. Thus, the side of the patch material may crack, but only in a portion of the patch material in that section, and most likely not the entire circular portion. Then, when the force subsides, the destroyed edge of the patch material is held together tightly by the portion of the heat-sealed tissue, and can reform mechanical bonds as well as low-energy chemical bonds, allowing the self-repairing of those materials while protecting tissues and organs from high pressure or anticoagulated bleeding.

[0263] In some embodiments, the patch material may be heated or cooled during or after injection within the device, within the needle, or onto, into, or near the target site. In some embodiments, this increases the temperature of the patch material, decreasing its viscosity and reducing the force required to expel the patch material from the device. In some embodiments, the patch material can serve to lower, increase, or otherwise alter the temperature of tissue or material at the target site.

[0264] In some embodiments, the thermal alteration of the patch material results in localized activation of the patch material. In other embodiments, the thermal effect used for tissue modification can partially or completely polymerize all or a portion of the patch material. This effect may be used in conjunction with light activation or alone, and in some embodiments may be used near certain portions of the device, at proximal or distal locations within the device, as the patch material exits the device, during activation of the patch material, or at any time or location, or any combination of these, to improve the "toughness" of the patch material within the device.

[0265] In some embodiments of the device, tissue alteration at the target location is induced by components of the device that include ultrasonic vibration ablation or tissue alteration. In these devices, many of the same advantages as those described above for tissue alteration by RF electrosurgery apply. However, embodiments utilizing ultrasonic ablation may include wireless ablation and instrumentation devices, which may allow easier control by the user. In some embodiments, the ultrasonic vibration ablation device may have an optional combination with a biocompatible patch material. This combination of ultrasonic ablation and biocompatible patch material allows the device to optimize the tissue targeted by the patch material, and can significantly improve tissue closure strength compared to either ultrasonic ablation or the patch material alone. Ultrasonic ablation can be used to modify the temperature, viscosity, toughness, adhesive strength, bond strength, or other aspects of the biocompatible patch material. In some embodiments, the biocompatible patch material used in combination is a photopolymerized patch material, a non-photopolymerized patch material, some other plug, mesh, substance, or some combination thereof. In some embodiments, the ablation and patch material can be selectively activated, altered, automated, semi-automated, or controlled in some other manner or combination thereof depending on the patient's comorbidities or risk factors. In some embodiments, the release and activation of the patch material, in addition to the use of ultrasonic ablation, allows for a reduction in the risk of complications. In patients with low or impaired clotting factors, low or degenerated platelets, severe disease, severe diseased tissues or organs, low RBC or hemoglobin counts, or a combination of these problems, the reduction in risks associated with the use of ultrasonic ablation in combination with patch material closure allows patients who are contraindicated to a particular procedure, surgery, or treatment to undergo that procedure, surgery, or treatment.In some embodiments, the patch material is a dual network photopolymerized gel used in conjunction with ultrasonic ablation to significantly reduce the risk of hemorrhage, bleeding from arterial sources or arterial vasculature, shorten repair times, reduce the toughness or viscosity required for the patch material, reduce the volumetric radial location or extent of tissue transformation associated with ablation of the target tissue, or other benefits, or combinations thereof. In some embodiments, the use of ultrasonic ablation in combination with the patch material may allow for improved closure of large, non-visible, or abnormal vascular structures.

[0266] In some embodiments, the ultrasonic ablation delivery component heats tissue in a controlled manner to temperatures of about 60°C to 100°C, similar to those of RF electrosurgery. In other embodiments, ultrasonic ablation raises the internal temperature to selectively denature the patch material. In some embodiments, the device uses oscillatory electronics to provide feedback, measurement, calculation, actuation, modification, and control of the ultrasonic ablation component. In some embodiments, the type, wavelength, frequency, or temperature produced by the device may be user controlled, automatic, or semi-automatic, and customized or optimized for one or more particular diseases, tissues, organs, coagulation disorders, locations, patch materials, or other factors, or combinations thereof.

[0267] In some embodiments utilizing RF electrosurgery, ultrasonic ablation, or other tissue modification mechanisms in conjunction with the patch material, temperature, bioimpedance, optical detection and measurement, other measurements, or combinations thereof may be used to optimize tissue for patch material adhesion, general hemostasis, arterial bleeding, tissue, organ, and other effects.

[0268] In some embodiments, thermal transformation of biological material (RF electrosurgery, acoustic heating, various other types of cauterization or heating, or various types of cooling) with placement of patch material and / or plugs to close the wound against high pressure bleeding after instrumentation may be performed, and the patch material may act as a heat sink. In some embodiments, the patch material acts as a heat sink in the area surrounding the biopsy specimen in the device. In some embodiments, the entire metal needle portion, a portion of the needle, or multiple needle portions are thermally conductive. The needle or the patch material not ejected from the device is not usually in direct contact with the specimen. However, in some embodiments, the patch material selectively has good thermal conductivity, as is all or a portion of the material wall surrounding the biopsy specimen holding compartment of the device. In some embodiments, after heat is absorbed (or provided) from the biopsy specimen, the thermally conductive portion of the patch material is circulated back to the bulk of the patch material or other heat sink to better distribute this thermal fluctuation. In some embodiments, the heating or cooling of the area surrounding the biopsy tissue affects chemical or mechanical bonds in the material, thereby modifying the properties of the patch material. In some cases, this thermal fluctuation reduces the viscosity of the patch material, which is beneficial for patch materials with highly viscous monomers such as polysaccharides, glycoproteins, or other molecules. These temperature fluctuations can provide the unexpected benefit of significantly reducing the force required to expel the patch material from the needle, and in some cases allowing the patch material to better conform to the tissue defect. The temperature of the patch material is raised to a temperature above approximately 38°C and below about 50°C so that the viscosity is reduced but the tissue is not further denatured by the patch material.

[0269] In other embodiments, the patch material has the advantage of lowering the temperature of the cells surrounding the puncture path after being exposed to thermal transformation. There is a risk that some parts of the tissue will undergo water removal or structural changes more quickly. In that scenario, the electrical impedance of this area may inadvertently increase, causing other parts of the tissue or biological material to receive a much higher conductive power, raising the temperature to unsafe levels. Releasing the thermally conductive patch material in the area of ​​the heated or cooled tissue can have the almost immediate effect of normalizing these temperatures to a safe level. This is particularly useful in tissues such as kidneys and lungs that cannot regenerate, thus preventing bleeding even at high pressures while protecting the remaining tissue from excessive thermal damage.

[0270] In some embodiments, the patch material extruded from the needle provides the unexpected advantage of preventing RF altered tissue from adhering to the insertion portion of the device.

[0271] In some embodiments of the device, the portion of the device that holds the biopsied specimen after it has been removed from the biopsy tissue bed has a flexible inner wall. In some embodiments that include a flexible inner wall in the biopsy specimen holding area, the lumen carrying the patch material passes through this flexible section of material via a continuous lumen, flattening the flexible area and significantly increasing the cross-sectional area of ​​this section of the needle, thereby greatly reducing the force and effort required to pass through this section, in some cases reducing it to less than one-quarter of that required with an unmodified biopsy needle. In some embodiments that include a flexible backing in the area where the biopsy specimen is stored, the patch material itself can be pulled back before, just before, during, or during the biopsy, so that the negative force in the lumen of the column containing the patch material can transmit negative pressure to the tissue, thereby drawing a section of the biopsy specimen into the cutting path and increasing the volume of the biopsy specimen. In the same device, the size of the outer defect containing the biopsy specimen can be reduced while still obtaining a similar specimen size with each use. In some embodiments, there is a flexible outer portion of the device that covers the external biopsy specimen area, which may be a portion of the outer cutting needle or a separate piece of the device. Again, if connected directly to the column of patch material and the inner flexible biopsy wall, this has the unexpected advantage that as the pressure of the patch material in the injection column increases, it exerts pressure directly on the biopsy tissue bed, allowing more volume through the patch material, reducing the force required to inject the patch material, making it easier for the patch material to adhere to the biopsy tissue bed, and facilitating hemostasis for bleeding at pressures above 140mmHG.

[0272] Because the vessels are not compressed (coapted) by the use of RF ablation from the needle, the patch material serves to increase the tensile rate of burst pressure.

[0273] Another reason for closing tissue with both patch material and RF electrosurgical coagulation and desiccation is that large or high pressure vessels damaged during biopsy cannot be coapted and compressed before closing with RF applied from the biopsy needle. Large diameter and high pressure vessels are usually closed only by compression, using distributed RF coagulation with low voltage continuous waveform energy. However, the combination can greatly increase the chances of bleeding prevention, because the energy of the vascular force and pulse can be better distributed throughout the surrounding tissue.

[0274] The burst pressure of the patch material delivered to the biopsy site or puncture tract after closure is approximately in the range of 100 mmHG to 200 mmHG.

[0275] V. Modular System In some embodiments, the tissue repair device is provided as a modular system, hi some embodiments, the modular system comprises a central unit that allows some components of the system to be removed to maintain sterility, while other components are retained within the central unit.

[0276] In some embodiments, the central unit comprises a light source. In some embodiments, the central unit comprises at least one computer processing system. In some embodiments, one or more sensors are provided in the sensor unit. In some embodiments, the central unit is loaded with a biocompatible patch material. In some embodiments, the biocompatible patch material is contained in a cartridge. In some embodiments, the central unit is loaded with a cartridge containing the biocompatible patch material. In some embodiments, the biocompatible patch material is specific to a target tissue type. In some embodiments, the cartridge containing the biocompatible patch material is labeled with a target tissue type.

[0277] In some embodiments, the modular system includes a light source located outside the central unit. In some embodiments, the light source is located within the needle or instrument. In some embodiments, the biocompatible patch material is located within a disposable. In some embodiments, a portion of the biopsy device is disposable. In some embodiments, all of the biopsy device is disposable. In some embodiments, a portion of the biopsy device is reusable. In some embodiments, all of the biopsy device is reusable.

[0278] In some embodiments, the modular system allows for a substance to be advanced through the needle to pre-load the instrument prior to insertion, hi some embodiments, the modular system is connected to biopsy instruments, vascular instruments, electrocautery instruments, surgical instruments, needles, endoscopic instruments, and combinations thereof.

[0279] In some embodiments, a modular system for 3D printing a biocompatible structure is provided. In some embodiments, the modular 3D printing system includes a removable nozzle for ejecting a biocompatible material. In some embodiments, the nozzle is selected based on the shape, location, or tissue type of the biopsy site. In some embodiments, the modular 3D printing system includes multiple interchangeable nozzles.

[0280] In some embodiments, the modular system allows for the selection of a particular patch material having a given type of tissue-modifying component, such as ultrasonic ablation, RF electrosurgery, thermal resistance ablation, freezing, some other tissue-modifying mechanism, or a combination of these.

[0281] In some embodiments, the modular system allows the user to individually select or control the type of tissue modifying components and patch material to optimize the device for a particular target, tissue, or risk factor. These selections may be simplified in some embodiments, so that the user can simply select a predefined combination to meet certain criteria for the target location, or a dial switch or control to selectively turn on or off different operations or components. In some embodiments, more complex selections are possible, such as cartridges of different patch materials to meet different needs for target tissue or organ location, disease type or severity, density diameter or size of local vasculature to the target location, cartridges for different tissue closure mechanisms, special wires and pads selectively used for monopolar cauterization operations, device modifications for attenuation of tissue modifying effects, other issues, or combinations of these. In some embodiments, the user can select one or more patch materials or patch material components or additives for light-activated or non-light-activated substances, such as, but not limited to, substance concentration, additives, and cure time, and cure time may be adjusted for a particular target, organ, disease, or combination of these factors. In some embodiments, all or portions of the device are pre-fitted with patch material or tissue alteration mechanisms. In some embodiments, there are several reusable parts that can be washed, coated, sterilized, autoclaved, or otherwise treated to prevent disease transmission while also reducing the cost of the product or its components.

[0282] In some embodiments, the device includes a method for using a modular system biopsy and patch system where a disposable cartridge is used for biopsy capture, mixing the patch material, partially polymerizing the patch material within the lumen of the device, delivering the partially polymerized patch material to a portion of the biopsy tract, and locking the portion of the disposable cartridge to prevent reuse. In some embodiments, the device includes a modular system biopsy and patch system where a disposable cartridge is used for biopsy capture comprised of a biodegradable light guide, mixing the patch material, partially polymerizing the patch material within the lumen of the device, and delivering the partially polymerized patch material to a portion of the biopsy tract.

[0283] 1. How to use the modular system in biopsy In some embodiments, the device includes a method for instrumentation and wound closure. Some embodiments are intended for use in performing a biopsy procedure and preventing hemorrhage by closing the biopsy tissue tract. In some embodiments, the user selects one or more instrument cartridges consisting of one or more biopsy needles for a particular biopsy procedure, a retractable waveguide, a patch material cartridge attachment site, a patch material component viewing window, accessories, and attachment sites for attachment to the housing of the device. The user then attaches the selected instrument cartridge to the device handle, which includes a handle, a housing, a number of controls, an instrument cartridge attachment point, and an instrument cartridge control component. In some embodiments, the user separately selects a patch material cartridge according to one or more variables related to the target organ, disease process, disease severity, other factors, or combinations thereof, and attaches it to the housing of the device (in some embodiments, the patch material cartridge comprises a portion of the instrument cartridge). In some embodiments, the user then connects a light source to the housing in a sterile manner. The user then presses the photopolymerization priming mechanism, which in some embodiments automatically performs a system check during the process to verify the viability of the patch material components, move the patch material components to the distal end of the needle, and mix the solutions of the two monomers with the photoinitiator component. The user then uses a separate or integrated imaging device to identify the target site, the instrumentation means, and any visible hazards or other problems. The user decides whether or not they intend to use the photopolymerization patch closure mechanism (when toggled to the on state, this occurs immediately after the biopsy procedure), and uses one external switch to turn the patch mechanism activation on and toggle both the release and closure activations on or off. The user then begins the procedure, which in some embodiments may be performed using standard techniques.Once the distal end of the device is aligned adjacent to the target biopsy tissue, the user then presses a biopsy activation button which activates the biopsy specimen collection mechanism, and immediately thereafter initiates patch activation within the distal lumen of the device to increase the strength and viscosity of the patch material, thereby closing the pathway even if the pathway is bleeding at high arterial pressure (up to about 300 mmHG) and anticoagulated blood. The patch material is pressed firmly from the distal end of the needle and light activated while in contact with the target tissue, simultaneously retracting the needle tip(s) towards the handle of the device (allowing for greater strength of the polymer column formed along the tissue biopsy pathway). The activation process also triggers an automatic locking mechanism to prevent repeated biopsy procedures triggered by the use of the light-polymerized patch. The patch closure mechanism continues for a period of about 5 seconds, hardening approximately 3 cm distal to the biopsy pathway. In some embodiments, upon completion, the removal indicator flashes and the needle can be safely removed from the patient. The user presses the excision step activation button, which serves to break up the photopolymerized gel to prevent specimen contamination. The user then presses the biopsy specimen retrieval button to remove the biopsy specimen. The user can then install a new instrument cartridge and repeat the process if they choose. This is only one example of many possible embodiments that perform instrumentation and wound closure, although the components, sequence, and type of procedure can vary greatly.

[0284] VI.Definitions Unless otherwise defined, all technical terms, notations, and other technical and scientific terms and terminology used herein are intended to have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter belongs. In some cases, terms having a commonly understood meaning are defined herein for clarity and / or ease of reference, but the inclusion of such definitions herein should not necessarily be construed as indicating that they are substantially different from those commonly understood in the art.

[0285] Throughout this application, various embodiments may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Thus, the description of a range should be considered to have specifically disclosed all possible subranges as well as individual numerical values ​​within that range. For example, the description of a range such as 1-6 should be considered to have specifically disclosed subranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, etc., as well as individual numerical values ​​within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0286] As used in this specification and claims, the singular forms "a," "and," and "the" include plural references unless the context clearly indicates otherwise. For example, the term "analyte" includes a plurality of samples, including mixtures thereof.

[0287] "Determining," "measuring," "evaluating," "assessing," "assaying," and "analyzing" are often used interchangeably herein to refer to forms of measurement. The terms include determining whether an element is present (e.g., detecting). Such terms can include quantitative, qualitative, or quantitative and qualitative determinations. Evaluating can be relative or absolute. "Detecting the presence of" can include determining the amount of something present in addition to determining whether something is present or absent depending on the context.

[0288] The terms "subject", "individual", or "patient" are often used interchangeably herein. A "subject" may be a biological entity containing expressed genetic material. The biological entity may be, for example, a plant, an animal, or a microorganism, including bacteria, viruses, fungi, and protozoa. A subject may be tissues, cells, and their progeny of a biological entity obtained in vivo or cultured in vitro. A subject may be a mammal. A mammal may be a human. A subject may be diagnosed or suspected to be at high risk for a disease. In some cases, a subject is not necessarily diagnosed or suspected to be at high risk for a disease.

[0289] The term "in vivo" is used to describe events that take place in the body of a subject.

[0290] The term "ex vivo" is used to describe events that occur outside of a subject's body. Ex vivo assays are not performed on a subject. Rather, the assay is performed on a sample that is separate from the subject. An example of an ex vivo assay performed on a sample is an "in vitro" assay.

[0291] The term "in vitro" is used to describe events that occur within a container for holding a laboratory reagent such that the laboratory reagent is isolated from the biological source from which the substance is obtained. In vitro assays can include cell-based assays in which live or dead cells are used. In vitro assays can also include cell-free assays in which no intact cells are used.

[0292] As used herein, a number followed by the term "about" refers to a number that is plus or minus 10% of that number. A range followed by the term "about" refers to a range of minus 10% of the minimum value and plus 10% of the maximum value.

[0293] As used herein, the term "treatment" or "treating" is used in reference to a pharmaceutical or other intervention regimen to obtain a beneficial or desired result in a recipient. The beneficial or desired result includes, but is not limited to, a therapeutic benefit and / or a prophylactic benefit. A therapeutic benefit may refer to the eradication or amelioration of the condition or underlying disease being treated. A therapeutic benefit may also be achieved by eradicating or ameliorating one or more of the physiological symptoms associated with the underlying disease, whereby an improvement is observed in the subject, even though the subject still suffers from the underlying disease. A prophylactic effect includes delaying, preventing, or eliminating the appearance of a disease or illness, delaying or eliminating the onset of symptoms of a disease or illness, slowing, halting, or reversing the progression of a disease or illness, or any combination thereof. For a prophylactic benefit, a subject at risk of developing a particular disease, or a subject reporting one or more physiological symptoms of the disease, even if the disease has not been diagnosed, may receive treatment.

[0294] As used herein, the term "arteriostatic" refers to agents or substances that prevent bleeding (eg, arterial bleeding, venous bleeding, and / or capillary bleeding) and hemorrhage.

[0295] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0296] VII. Exemplary Embodiments Manually Operated Biopsy and Biopsy Site Repair Device - Patent application According to some embodiments, the tissue repair device and associated components are illustrated in Figures 1A-2D. In some embodiments, as illustrated in Figures 1A-1E, the tissue repair device may comprise a body (105) and a needle (120). In some embodiments, the needle (120) is a biopsy needle with a specimen tray (130) for collecting a tissue specimen. In some embodiments, the specimen collection tray (130) may be contained within or covered by a sheath (150). In some embodiments, the sheath (150) is configured as a cutting sheath. In some embodiments, a shield (155) is provided to prevent contamination of the body (105) of the device. In some embodiments, the shield (155) may be manipulated to manually translate the sheath (150).

[0297] In some embodiments, the device includes a reservoir (140) for containing the biocompatible patch material. In some embodiments, the sheath (150) is translated proximally toward the body (105) to expose the reservoir and the biocompatible patch material. In some embodiments, the needle is provided with one or more openings (121), (122), (123) in fluid communication with a reservoir (124) of the biocompatible patch material. In some embodiments, the reservoir (140) includes an interior portion (124) that extends into the needle and / or the body of the device. In some embodiments, a lumen (126) provides and enables transport of the biocompatible patch material through the device and through the openings. In some embodiments, a plunger (125) is provided for translating the biocompatible patch material through the fluid circuit to the target area.

[0298] In some embodiments, the device includes a light source (115). In some embodiments, the light source is housed within the body. In some embodiments, the light source is provided at the distal end of the device. In some embodiments, one or more optical elements direct light from the light source to one or more light emitters (110). Light emitters may be provided within the lumen of the needle or on the outer surface of the needle. In some embodiments, apertures (122), (123) are utilized as light emitters. In some embodiments, activation of the light source, release of the biocompatible patch material, translation of the cutting sheath, or a combination thereof is initiated by a user pressing a plunger or button. In some embodiments, one or more light diffusing and / or transparent covers (112) are provided to transmit light to the dispensed patch material while preventing material from entering the tip of the needle.

[0299] Automatic biopsy site repair device 11A-17D, a device for automated tissue biopsy collection and repair at a biopsy site is illustrated, according to some embodiments. In some embodiments, a biopsy site tissue repair device (1100) is provided that comprises a housing (1101). In some embodiments, the housing (1101) holds components of a cocking mechanism for the device. The cocking mechanism allows for simple loading or cocking and subsequent activation of the device to collect a tissue sample using a biopsy needle (1120), dispense a biocompatible patch material, and emit light to cure said biocompatible patch material.

[0300] In some embodiments, the housing (1101) includes a needle cartridge recess (1151) for removably receiving a needle cartridge (1150). In some embodiments, a user first loads the needle cartridge (1150) into the housing (1101). In some embodiments, the user activates the cocking mechanism after loading the needle cartridge by engaging the cocking trigger (1110). In some embodiments, the user engages the cocking trigger (1110) by moving it toward the proximal end of the device (1100). In some embodiments, the user engages the cocking trigger (1110) by moving it toward the distal end of the device (1100). The user then inserts and positions the needle (1105) at the biopsy site and depresses the activation button (1140). In some embodiments, depressing the activation button (1140) releases the cocking mechanism. In some embodiments where the needle (1120) is a biopsy needle, when the activation button (1140) is depressed to release the cocking mechanism, the sample tray moves relative to the outer sheath of the biopsy needle such that a tissue sample is excised from the biopsy site and retained in the sample tray. In some embodiments, depression of the activation button (1140) dispenses a biocompatible patch material from the distal end of the needle (1120) into the biopsy site. In some embodiments, the device (1100) further comprises a light source (1190) disposed within a light source recess in the housing (1191). In some embodiments, depression of the activation button (1140) results in activation of the light source (1190). In some embodiments, the light source (1190) is used to cure the light-activated biocompatible patch material as described herein.

[0301] In some embodiments, the needle cartridge (1150) comprises a proximal needle wing (1152) and a distal needle wing (1154) of the housing (1101). In some embodiments, the proximal needle wing (1152) is coupled to an inner needle (1122) of the biopsy device. In some embodiments, the inner needle (1122) comprises a specimen tray for collecting and holding a tissue specimen. In some embodiments, the distal needle wing (1154) is coupled to an outer needle or sheath (1124) of the biopsy device.

[0302] In some embodiments, when the cocking trigger (1110) is pulled proximally, the proximal needle wings (1152) and the distal needle wings (1154) are positioned in a proximal position and the inner needle (1122) and the outer needle (1124) are positioned in a retracted position. This may be referred to as a first position. The cocking action and the first position are illustrated in Figures 12C and 12F according to some embodiments. After depression of the activation button (1140), the proximal needle wings (1152) and the inner needle (1122) move distally such that the specimen tray of the inner needle is exposed from the outer needle or sheath (1124). This may be referred to as a second position and is illustrated in Figure 12D according to some embodiments. After a second press of the activation button (1140), the proximal needle wing and the outer needle or sheath (1124) move distally such that the outer needle or sheath (1124) covers the specimen tray of the inner needle (1122) and contains the specimen. In some embodiments, this movement results in the excision of a tissue specimen as disclosed herein. This position may be referred to as the third position. After a third press of the activation button (1140), the biocompatible patch material is pushed through the lumen of the needle and dispensed at the biopsy site. This may be referred to as the fourth position and is illustrated in FIG. 12D according to some embodiments. In some embodiments, this position activates the light source to activate a photoinitiator in the biocompatible patch material. In some embodiments, the cartridge (1150) may be filled with the patch material via the opening (1370). In some embodiments, tabs (1335) and edges (1330) fit into housing (1101) to lock cartridge (1150) in place.

[0303] 12A-16F, further details of an automated biopsy and biopsy site repair device (1100) and its components are illustrated, according to some embodiments. In some embodiments, the device (1100) comprises a carrier cage (1500) and a cocking plate (1400). In some embodiments, the carrier cage (1500) comprises a proximal wing carrier (1554) and a distal wing carrier (1552). In some embodiments, the proximal wing carrier (1554) is biased distally by a spring (not shown) abutment surface (1553). In some embodiments, the distal wing carrier (1552) is biased distally by a spring (not shown) abutment surface (1551). In some embodiments, the transport cage (1500) is biased proximally by a spring (not shown) abutment surface (1551) of the transport cage (1500) and surface (1112) of the housing (1101). As shown, a recess may be provided to retain the spring.

[0304] In some embodiments, the cocking mechanism comprises a cocking plate (1400). The cocking plate (1400) may be referred to as having a partially circular or toroidal shape. In some embodiments, the cocking plate (1400) comprises a spring (1495) (shown in FIGS. 14F and 14K) that biases the plate. In some embodiments, as shown, the spring (1495) biases the plate (1400) in a counterclockwise direction. In some embodiments, the plate comprises a number of teeth that engage with a cog (1490) (as shown in FIGS. 14I and 14L). In some embodiments, the cog (1490) comprises an outer diameter (1492) having a number of teeth and an internal detent (1494). In some embodiments, the internal detent (1494) of the cog (1490) fits within a gear (1485) that comprises a directional arm (1487) to form a one-way locking gear. In some embodiments, the gear (1485) comprises an outer diameter having a plurality of teeth (1489) that engage with the teeth of the cocking rack (1480). In some embodiments, the cocking rack (1480) is coupled to the cocking trigger (1110) by a cocking slide (1481), a cocking bar portion (1482), a cocking pull portion (1483), and a cocking lever (1484). In some embodiments, the configuration is such that when a user actuates the cocking trigger, vertical motion is translated through the cocking lever (1484) resulting in vertical motion of the cocking rack (1480) in a proximal direction. In some embodiments, the proximal motion of the cocking rack (1480) rotates the gear (1485) and cog (1490), thereby rotating the cocking plate (1400) and creating a bias by the spring (1495).

[0305] In some embodiments, the locking plate (1400) includes four recesses (1401), (1402), (1403), (1404) that engage the cocking pawl (1405). In some embodiments, the cocking pawl (1405) is biased into the recesses (1401), (1402), (1403), (1404) by a spring (not shown) that has one end held in a recess (1405A) of the cocking pawl (1405). In some embodiments, the cocking pawl (1401) is actuated by extension of an actuation button (1440) that includes a ramped portion such that the pawl is withdrawn from the recess and the engagement plate can rotate until the locking pawl engages the next recess. In some embodiments, this configuration allows rotation through all positions if the actuation button (1440) is held down by the user. In some embodiments, the recesses correspond to the four positions of the device referred to herein, with recess (1401) corresponding to a first position immediately after cocking, recess (1402) corresponding to a second position after a first depression of the activation button, recess (1403) corresponding to a third position after a second depression of the activation button, and recess (1404) corresponding to a fourth position after a second depression of the activation button. In some embodiments, the mating configuration of gear (1485) and cog (1490) provides a one-way pawl so that the gear does not resist or translate the cocking rack (1480) as the locking plate (1400) rotates under the bias of the spring. In some embodiments, the cocking pawl (1405) contacts the outer surface of the locking plate as it rotates. In some embodiments, this contact provides friction to slow the rotation of the locking plate after the activation button is actuated.

[0306] In some embodiments, the wing carriers (1554), (1552) include tabs (1563), (1561) that engage recesses (e.g., recesses (1567) shown in Figures 15D and 15E). In some embodiments, depression of the actuation button actuates angled portions of the tabs, disengaging them from the corresponding recesses.

[0307] The locking plate also includes a distal wing carrier cam surface (1454) and a proximal wing cam surface (1452) that urge the distal wing carrier (1554) and the proximal wing carrier (1552) respectively (against the bias of their respective springs) towards a proximal position as the locking plate (1400) rotates during cocking of the device. In some embodiments, the corresponding abutment surfaces ((1564) and (1562), respectively) of the distal wing carrier cam surface (1454) and the proximal wing cam surface (1452) are illustrated in Figures 15B-15E. In some embodiments, when the needle cartridge (1150) is inserted into the needle cartridge recess (1551) of the device (1100), the distal wing carrier (1554) and the proximal wing carrier (1552) couple to the proximal needle wing (1152) and the distal needle wing (1154), respectively. Thus, when the locking plate (1400) is rotated through their positions, the needle wings are positioned as described above.

[0308] In some embodiments, the transport cage (1500) comprises a cartridge wing recess (1562) for receiving the patch actuator wing (1362) of the patch actuator (1362). In some embodiments, the transport cage (1500) further comprises a lower extrusion (1556) that abuts the transport cocking cam surface (1456) of the cocking plate (1400). In some embodiments, when the cocking plate moves beyond the fourth position, the transport cage is biased upward by a corresponding spring. This in turn pushes the patch actuator (1362) upward, which in turn retracts the needle assembly. If patch material is provided within the patch material storage cell (1324) of the needle cartridge (1150), the patch material is extruded through one or more openings provided proximal to the distal end of the needle assembly, as discussed herein.

[0309] In some embodiments, upward movement of the patch actuator (1362) actuates a lever (1365) to open and provide an opening for light emitted from the light source (1190) to reach the light receptor. In some embodiments, a needle-integrated light receptor (1330) is provided to receive light from the light source through this open opening and act as a waveguide to transmit the light to the body site to be treated. In some embodiments, the locking plate (1400) is provided with a light source actuation protrusion (1430) which in turn actuates the light source for photoinitiation of the photopolymerized biocompatible patch material.

[0310] In some embodiments, the device further comprises a toggle switch (1130). In some embodiments, the toggle switch (1130) is provided in a proximal position to allow the biocompatible patch material to be dispensed and the light source to be activated. In some embodiments, the toggle switch (1130) is provided in a proximal position to prevent dispensing of the biocompatible patch material and leave the light source in an inactivated state. In some embodiments, the toggle switch, in the proximal position, prevents the needle from retracting. FIGS. 16A-16D illustrate the toggle switch (1130) according to some embodiments. In some embodiments, sliding the toggle switch (1130) to a distal position rotates the toggle wheel (1635) and presses the lock (1640) against a bottom portion of the locking plate (1400), preventing the locking plate from moving upwards due to the bias of the spring, thereby preventing the patch actuator from moving upwards. In some embodiments, the upper protrusion of the stop (1640) abuts to prevent this.

[0311] One skilled in the art will appreciate that components of the device can be modified to create a desired outcome or treatment. For example, the needle cartridge may be modified such that the device only provides tissue repair and does not perform a biopsy. In another example, the needle cartridge may provide a biocompatible patch material that is not light activated, and thus it may be desirable to provide a modified needle cartridge that does not allow activation of the light source and / or blocks transmission of the light source. For example, Figures 16A-C.

[0312] It will further be understood that the device and its components can be further modified as described herein. For example, a needle cartridge may be provided with the components necessary for cauterization, or the mechanical components of the device may be replaced with electrical, pneumatic, and / or magnetic components. Additionally, mechanical delays may be introduced to alter the timing of components. However, it will be understood that a fully mechanical device of some embodiments may achieve a lower cost per unit.

[0313] Lever action biopsy site repair device 21A-21D, a biopsy site repair device is illustrated according to some embodiments. In some embodiments, the device includes a patch material storage chamber (2102) having a rear plunger (2104) and an exhaust port (2106). In some embodiments, a tubular connecting pathway (2108) fluidly connects the patch material in the storage chamber to the lumen (2010) of the needle (2120). In some embodiments, a one-way valve (2109) is provided along the tubular conduit (2108). In some embodiments, the device includes a patch delivery lever (2112) that translates along one or more sliding guide arms (2114). In some embodiments, the device includes a patch delivery lever rest (2116).

[0314] In some embodiments, the device comprises a light source (2130) for activating a photoinitiator in the patch material. In some embodiments, the device comprises a receiving lens (2132) for collecting and collimating the light. In some embodiments, a wavelength selection filter (2134) filters out the wavelengths of the light source. In some embodiments, the device comprises a proximal beam collector (3136) and / or an internal collector (3138) for directing the light into the proximal end of the waveguide (3140). In some embodiments, the waveguide (3140) is disposed in a waveguide shaft (3142) and directs the light from the light source to the distal end of the needle.

[0315] In some embodiments, the device includes a patch material plunger (2150) provided for moving patch material through a patch dose holding chamber (2152). In some embodiments, a lever is raised near the patch dose holding chamber, filling the chamber (2152) with patch material (as shown in FIG. 21B). The lever is then depressed, forcing the patch material from the chamber (2152) through a one-way valve (2154) and out of the lumen of the needle (2120). In this manner, a desired amount of patch material may be initially loaded into the chamber (2152) and then dispensed through the lumen of the needle. FIG. 21D illustrates a similar device with two material storage chambers, according to some embodiments.

[0316] Photoconductive Catheter In some embodiments, the tissue repair device is placed at the target site using a catheter. A light-conducting catheter may be ideal to prevent damage to the organ, allowing activation of the light-polymerized patch material over a long period of time without risk of damaging the biological structure. A light-conducting catheter according to some embodiments is illustrated in Figures 6A-6D. In some embodiments, the core needle (620) and cutting needle (640) are retracted into the light-conducting catheter (660), which is flexible enough not to harm the tissue, structure, or organ, but has the strength to withstand the puncture pressure from the needle to further protect the tissue. In some embodiments, the core needle and cutting needle can be completely removed from the organ or tissue at high risk of bleeding. Very importantly, this embodiment allows the user to have a regular flow of action while still having the great advantage of the patch material being released to prevent high pressure bleeding, heavy bleeding, or hemorrhage in tissues, organs, or patients where normal clotting mechanisms are compromised. In some embodiments, this mechanism allows the light-activated gel to safely cure for 10 seconds, 30 seconds, 1 minute, 5 minutes, or 30 minutes, even with significant patient, device, and organ movement, without risk of needle damage.

[0317] The biopsy is advanced so that the biopsy is advanced to the tip of the core needle immediately after it is excised. The patch material then begins to be released from the inner lumen of the core needle. The photopolymerized gel is released from the distal end of the needle. The patch material within the light-conducting catheter remains at its distal end, providing some pressure against the wall. The wall of the light-conducting catheter, in some embodiments, has small holes to allow more patch material to be released at the specific location of the biopsy.

[0318] In some embodiments, the light-conducting catheter also functions as an electrical resistor. This allows an optimal amount of the distal end of the device to denature tissue 0-6 cm distally before dispensing patch material. In some embodiments, the distal end of the needle (core needle and cutting needle) functions as a monopolar electrode for RF electrocautery. This device allows the user the unique advantage of being able to selectively activate zero, one, two, or more of the hemostatic measures while using a single device and simple controls. For example, a patient with new onset renal disease with a normal coagulation system who has no risk factors may only require patch material (not photopolymerized) to reduce the likelihood of massive bleeding to near zero percent. Patients with advanced renal disease have a variety of factors, many of which have not been previously identified, that increase the likelihood of massive bleeding. These patients are likely to require significant photocuring of the patch in addition to placement of the photopolymerized patch material to reduce the risk of massive bleeding to an acceptable level. Many patients who require liver, kidney, colon prostate, brain, lung, or other types of biopsies have significant problems with their innate coagulation system. There may also be a risk of other materials, liquids, substances, or air leaking into or contaminating unintended areas, and therefore these biopsies require both tissue modification (such as monopolar electrosurgery) and light-activated gel release and hardening closure, all of which the present invention again allows without significantly altering the user experience.

[0319] In alternative embodiments of this type, the device may use bipolar electrosurgery, thermal cauterization, cryo, acoustic cauterization, or some other form of tissue denaturation or hemostasis in addition to the release of patch material.

[0320] Of note, in the "optical catheter embodiment," there are some embodiments that have a second catheter that surrounds the needle and the proximal end of the optical catheter. This serves multiple unexpected purposes, since it can be used as a stable base that automatically creates friction to hold the position of the device against the tissue and organs. This can be utilized to pull the optical catheter at a specific speed so that the photopolymerized gel can be properly cured. This second catheter can also be used to shield other tissues and biological materials from the photons, thereby allowing the device to target only the wound or the patch material, or both. In some embodiments, some photopolymerization may occur while the patch material is in the lumen of the optical catheter after exiting the needle. This may allow for increased toughness of the patch material before it is exposed to high pressure or turbulent bleeding. There may also be multiple openings, diffusion regions, shielding regions that emit fewer photons, other components, or some combination of these. In some embodiments, the inner lumen of the device emits a lower amount of photons than the outer portion, thereby promoting complete polymerization at the tissue site.

[0321] The light catheter may also be used in combination with ablation or other types of tissue modification, with which the light polymerized patch material is combined. The light delivery catheter, or another catheter, some other surrounding material, or a combination of these, may be used to attenuate or prevent the tissue modification mechanism from affecting tissue or material outside the target area.

[0322] The light delivery catheter may also be used in some embodiments to protect the tissue from sharp or blunt trauma from the tip of the biopsy needle. This may also have the advantage of allowing the light diffusing portion of the device to remain safely within the patient, organ, tissue, or material for a longer period of time, which has the unexpected benefit of improving both the safety of the device and the versatility of the patch material and components of the device.

[0323] With regard to the delayed / timed withdrawal of the light projection element, this can be accomplished in many ways, by various embodiments of mechanical, electronic, magnetic, or other methods. In some embodiments, the viscosity of the patch material that resists movement can be used to automatically control the withdrawal speed. For example, if a helical pump screw is mounted in the central lumen of the core needle, the pump screw is mechanically coupled to both the rotation of the patch driving force of the device and the mechanical withdrawal of the light source and / or needle, and thus the rotation and release of the patch material to the target location can also be used to resist the driving force of a spring or motor, thereby automatically and mechanically controlling the movement speed of the light source. The cartridge containing the patch material can also adjust the flow rate of the patch material, or the light intensity or operation of the light source, or other, or some combination of these.

[0324] VIII. Examples The following examples are included for illustrative purposes only and are not intended to limit the scope of the invention.

[0325] Exemplary Methods of Biopsy and Subsequent Biopsy Site Repair 41A-41F illustrate a biopsy and subsequent biopsy site repair using a biocompatible patch material and a balloon to provide compression to the biopsy site. The biocompatible patch material may be a light-initiated patch material as disclosed herein. One or more components of the device may be configured as a waveguide to propagate light to activate the patch material. A lumen may be provided through the inner cannula of the biopsy needle. The lumen may be connected to a pneumatic device for inflation of the balloon. In some embodiments, the light is propagated through the balloon.

[0326] In some embodiments, the first step is illustrated in FIG. 41A where the biopsy needle begins to insert into the biopsy site. In some embodiments, the second step is illustrated in FIG. 41B where the inner needle of the biopsy needle with the specimen tray is fully inserted into the biopsy site. In some embodiments, the third step is illustrated in FIG. 41C where the outer lumen or sheath of the biopsy needle moves to cover the specimen tray to contain the tissue specimen. In some embodiments, the plunger pushes against the biocompatible patch material as or...

Claims

1. 1. A device for delivering a biocompatible patch material to a biological site, the device comprising: A housing, cocking mechanism, and a button adapted to release the cocking mechanism a housing comprising: A cartridge, a storage compartment containing the biocompatible patch material; and a needle having a lumen in fluid communication with the storage compartment; a cartridge comprising: Equipped with The device wherein the cartridge is mechanically coupled to the cocking mechanism such that actuation of the button dispenses the biocompatible patch material from the distal end of the needle.

2. The device of claim 1 , wherein the needle is a biopsy needle.

3. 3. The device of claim 2, wherein actuation of the button activates the biopsy needle such that the biopsy needle sheath covers the biopsy needle specimen tray, thereby capturing a tissue specimen from the body site.

4. The device of claim 3 , wherein actuation of the biopsy needle occurs before dispensing of the biocompatible patch material from the distal end of the needle.

5. 2. The device of claim 1, wherein the cocking mechanism includes a cocking plate, and actuation of the cocking mechanism rotates the cocking plate against the bias of a spring to lock the cocking plate in a first position.

6. 6. The device of claim 5, wherein actuation of the button releases the cocking plate so that the cocking plate moves to a second position, and when the cocking plate is in the second position, the needle specimen tray is not covered by a sheath.

7. 7. The device of claim 6, wherein a second actuation of the button releases the cocking plate so that the cocking plate moves to a third position, and the sheath covers the specimen tray of the needle when the cocking plate is in the third position.

8. 8. The device of claim 7, wherein a third actuation of the button releases the cocking plate so that the cocking plate moves to a fourth position, and the biocompatible patch material is dispensed from the distal end of the needle when the cocking plate is in the fourth position.

9. The apparatus of claim 8 , further comprising a light source that emits light when the cocking plate is in the fourth position.

10. The device of claim 9 , further comprising a waveguide that propagates light from the light source to the distal end of the needle.

11. 11. The apparatus of claim 10, wherein light from the light source is blocked from entering the waveguide until the cocking plate is in the fourth position.

12. The apparatus of claim 1 further comprising a light source.

13. The device of claim 12 , further comprising a waveguide that propagates light from the light source to the distal end of the needle.

14. The device of claim 12 , wherein the housing comprises a cavity that accommodates the light source.

15. The device of claim 14 , wherein the light source is removably housed in the housing.

16. The device described in claim 1, wherein operation of the button extends at least a portion of the needle from the housing and activates the release of the cocking mechanism so that the biocompatible patch material is dispensed through the retractable needle.

17. The device of claim 1, wherein the needle is configured for cauterizing the biological site.

18. The device of claim 17, wherein the needle cauterizes the biological site using thermal cauterization, RF cauterization, ultrasonic cauterization, chemical cauterization, electrocauterization, cryocauterization, or a combination thereof.

19. The device of claim 1, wherein a heat source is provided proximate to or adjacent to the lumen or the storage compartment so that the biocompatible patch material is heated and reduced in viscosity.

20. The device described in claim 19, wherein the biocompatible patch material is heated to reduce its viscosity from greater than about 1000 cp to less than 500 cp.

21. A needle having a lumen with an outlet; a light emitter disposed on the surface of the needle or within the lumen of the needle; a fluid circuit connecting a fluid reservoir to the outlet of the lumen; An apparatus comprising:

22. The device described in claim 21, wherein the fluid reservoir holds a biocompatible repair material.

23. The device described in claim 22, wherein the biocompatible repair material includes a photoinitiator.

24. The device of claim 21, wherein the needle further comprises a specimen tray and a sheath.

25. The device described in claim 24, wherein the sheath moves parallel to the axis of the needle to contain the sample tray.

26. The device of claim 22, wherein the needle further comprises a sheath, the sheath being adapted to translate proximally along the axis of the needle to expose an opening to the fluid reservoir.

27. The device of claim 26, wherein the needle further comprises a specimen tray, and the sheath translates distally along the axis of the needle to contain the specimen tray.

28. The device described in claim 27, wherein parallel translation of the sheath along the axis of the needle facilitates removal of a tissue sample from tissue.

29. The device described in claim 28, further comprising a syringe having a body and a plunger, wherein pushing the plunger toward a of the device causes the biocompatible repair material to be released from the outlet, activates the light emitter, and translates the sheath in the distal direction to remove the tissue sample from the tissue, and contains the sample tray.

30. The device described in claim 22, further comprising a syringe having a body and a plunger, wherein pushing the plunger toward a of the device causes the biocompatible repair material to be released from the outlet and activates the light emitter.

31. The device of claim 21, wherein the needle is configured as a cauterizing needle.

32. The device of claim 31, wherein the ablation needle ablate the biological site using thermal ablation, RF ablation, ultrasonic ablation, chemical ablation, electrocautery, cryoablation, or a combination thereof.

33. The device described in claim 23, wherein a portion of the biocompatible repair material is activated within the lumen.

34. The device described in claim 22, wherein the biocompatible repair material comprises a dual network material.

35. The device of claim 22, wherein the biocompatible repair material is provided in a cartridge.

36. The device described in claim 35, wherein the cartridge is housed in the device, and by housing the cartridge, the biocompatible repair material is provided in fluid communication with the fluid circuit.

37. The apparatus of claim 21, further comprising a heat source.

38. The device described in claim 37, wherein the heat source transfers heat to a portion of a biocompatible patch material within the fluid circuit.

39. The device of claim 24, wherein the sheath rotates around the axis of the needle to contain the sample tray.

40. The device described in claim 1, wherein the cocking mechanism includes a cocking plate having a plurality of positions, and wherein a single depression of the button is adapted to cause the button to progress through the plurality of positions on the cocking plate.

41. The device of claim 1, further comprising a toggle switch adapted to dispense the biocompatible patch material.

42. The device of claim 1, further comprising a cocking lever adapted to reset or prime the needle to an initial position, thereby preparing the biocompatible patch material for dispensing from the needle.

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