GB2514444A

GB2514444A - Injection applicator and alignment device and related methods of use

Info

Publication number: GB2514444A
Application number: GB1404066.1A
Authority: GB
Inventors: Wilhelmus Petrus Martinus Maria Van Erp; Tommy Robert Oscar Martens; Roy Wijman
Original assignee: Elekta AB
Current assignee: Elekta AB
Priority date: 2013-03-15
Filing date: 2014-03-07
Publication date: 2014-11-26
Also published as: GB201404066D0

Abstract

An applicator for controlling the insertion of a plurality of needles into a body of a patient is disclosed, comprising a needle housing 1 having a proximal region and a distal region, a needle holder 4 slideably disposed within the needle housing and configured to retain a plurality of needles 5a, 5b, 5c; wherein the plurality of needles are configured to transition between a retracted configuration wherein the needles are withdrawn within the needle housing and an extended configuration wherein the needles protrude from the distal region of the needle housing. The needle holder is preferably moved by a plunger 2, however alternatives include an electromagnet (12, see figure 1E), pneumatic or hydraulic pressure (see figure 1F) or slide grips (8, see figure 1D). An alignment device may be used with the applicator. The applicator may be connected to an afterloader and used to deliver a treatment including radiation.

Description

INJECTION APPLICATOR AND ALIGNMENT DEVICE

AND RELATED METHODS OF USE

Field of the Disclosure

[001] Embodiments of the present disclosure relate to applicators, and more particularly, needle applicators for fixating, aligning, and inserting one or more needles into a predetermined area of tissue.

Background of the Disclosure

[002] Many different medical treatment or diagnostic procedures require administering one or more needles into a region of the body. Though healthcare providers and patients insert such needles on a regular basis, achieving the correct angle of insertion or depth of insertion and/or penetrating the correct internal area can prove difficult even when the exact target area is known, for example, through the use of imaging or other means. This may be due to the deformation of the body when needle pressure is applied and/or slight movements by the patient or the healthcare provider prior to or during insertion. For some procedures, however, precise insertion is crucial to the treatment or diagnosis.

[003] For example, some cancer treatments, like interstitial brachytherapy (IRT), require the precise delivery of a substance (e.g., a radioactive substance) to a target area of tissue. IRT may be used to treat a variety of cancers, including prostate, cervical, endometrium, skin, bronchial, esophageal, head and neck, and breast cancer.

During IRT, radioactive sources may be delivered into or next to a treatment area, e.g., a tumor. This may allow a more concentrated dose of radiation to be delivered from within a tumor, decreasing radiation exposure to the surrounding tissue.

[004] Low dose-rate (LDR) IRT may use longer-term internal radiation delivery.

To accomplish this, one or more needles or catheters may be inserted through the skin and into or next to the tumor area. Once the needle(s) and/or catheter(s) penetrate the target area, a radioactive source or radioactive materials, for example, radioactive seeds or implanted wires, may be delivered to the tumor area. The implants may be placed for several days or permanently.

[005] High dose-rate (HDR) IRT may deliver a more concentrated source of radiation over a shorter period of time. A radioactive source may be delivered through an applicator that has been placed on or in a patient. For example, guide tubes, e.g., catheters, trocars, or hollow needles, may operably couple an applicator to an afterloader and may provide a pathway for radioactive materials to flow from the afterloader and into the body. The source may then be allowed to dwell in various positions along the length of the guide tubes, releasing doses of radiation delivered from the afterloader as it travels.

[006] For LDR and HDR IRT treatments, radioactive sources must be delivered accurately to small areas. Target areas may be on the scale of tens of millimeters in diameter, or in some cases, may be even smaller. Additionally, if multiple needles or sources are used, each may need to penetrate the target area. Radiation sources must be carefully aligned for delivery to precise, and often in hard-to-reach, areas. Thus, to accurately deliver radiation to the targeted region of tissue, a precise and consistent angle, depth, and location of insertion must be achieved. Additionally, a need exists for a device capable of compensating for or adjusting to movements by the patient and/or the person administering the treatment. The present disclosure aims to overcome at least some of these deficiencies in the prior art.

I. Brief Description of the Drawings

[007] The accompanying drawings illustrate certain exemplary embodiments of the present disclosure, and together with the description, serve to explain principles of

the present disclosure.

[008] Figure IA illustrates a perspective view of an exemplary injection applicator device, according to an embodiment of the present disclosure; [009] Figure lB depicts a side cutaway view of the exemplary deployment mechanism of the injection applicator device of Figure 1A; [010] Figures ic-i H depict side cutaway views of exemplary deployment mechanisms for use with exemplary injection applicator devices, according to

embodiments of the present disclosure;

[011] Figures 2A-2B depict exploded views of exemplary deployment mechanisms for use with an injection applicator device, according to embodiments of

the present disclosure;

[012] Figures 3A-3B depict various views of exemplary needle positioning components for use with an injection applicator device and an insertion positioning device, according to embodiments of the present disclosure; [013] Figure 4 depicts various views of exemplary needles for use with an injection applicator device, according to embodiments of the present disclosure; [014] Figures 5A-SB depict various views of exemplary fixation methods for use with an injection applicator device, according to embodiments of the present

disclosure;

[015] Figures 6A-60 depict perspective views of various alignment templates, according to exemplary embodiments of the present disclosure; [016] Figure 7 depicts various views of an exemplary alignment mechanism, according to an exemplary embodiment of the present disclosure; [017] Figure 8 depicts various views of exemplary alignment mechanisms, according to further embodiments of the present disclosure; [018] Figures 9A-9B depict perspective views of exemplary alignment mechanisms, according to exemplary embodiments of the present disclosure; [019] Figure 10 depicts a perspective view of an exemplary alignment mechanism, according to exemplary embodiments of the present disclosure; [020] Figure 1 1A illustrates a perspective view of an exemplary alignment connector, according to exemplary embodiments of the present disclosure; [021] Figure I1B illustrates a cutaway view of an exemplary alignment connector, according to exemplary embodiments of the present disclosure; [022] Figure 12 depicts various views of exemplary safety mechanisms for use with an exemplary injection applicator device, according to an embodiment of the

present disclosure;

[023] Figure 13 depicts a perspective view of an exemplary alignment mechanism, for use with an exemplary injection applicator device, according to an

embodiment of the present disclosure;

[024] Figure 14 depicts a perspective view of an exemplary alignment mechanism and an exemplary injection applicator mechanism, according to an

exemplary embodiment of the present disclosure;

[025] Figure 15 depicts various views of an exemplary preliminary alignment mechanism and an exemplary injection applicator mechanism, according to an exemplary embodiment of the present invention; [026] Figures 16A-16C depict various cutaway views and alternate configurations of an exemplary alignment mechanism, according to an exemplary

embodiment of the present disclosure;

[027] Figure 1 7A depicts a perspective view of an exemplary alignment mechanism, according to an exemplary embodiment of the present disclosure; [028] Figures 17B-17C depict alternate configurations of the exemplary alignment mechanism of Figure 1 7A, according to an exemplary embodiment of the

present disclosure;

[029] Figure 1 7D depicts a cutaway view of an alternate configuration of the exemplary alignment mechanism of Figures 17A-17C, according to an exemplary

embodiment of the present disclosure; and

[030] Figures 1 8A-1 8B depict perspective views of an exemplary alignment mechanism, according to an exemplary embodiment of the present disclosure.

II. Detailed Description

[031] Reference will now be made in detail to the exemplary embodiments of the present disclosure described above and illustrated in the accompanying drawings.

Wherever possible, the same reference numbers will be used throughout the drawings to refer to same or like parts.

[032] While the present invention is described herein with reference to illustrative embodiments for particular applications, such as, for use in connection with IRT for breast tissue and breast cancer, it should be understood that the embodiments described herein are not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments, and substitution of equivalents all fall within the scope of the invention. For example, the principles described herein may be used with any suitable needle or catheter injection device (e.g., standard injection needles, intravenous catheters, biopsy needles, etc.) for any suitable treatment or diagnostic purpose (e.g. biopsies, drug delivery, etc.). The embodiments may be configured for use with any suitable body region, e.g., for prostate or gynecological uses. Accordingly, the invention is not to be considered as limited by the foregoing or following descriptions.

[033] Other features and advantages and potential uses of the present disclosure will become apparent to someone skilled in the art from the following description of the disclosure, which refers to the accompanying drawings.

Needle Insertion [034] Figure 1 depicts an injection applicator device 10, according to an exemplary embodiment of the disclosure. Device 10 may include a plunger 2 and a needle housing I. Needle housing I may be at least partially hollow and configured to house one or more needles 5a-5c. Needle housing 1 may include a proximal end oriented closer to a user while the device is in use and a distal end oriented closer to the body of a patient during use. The distal end may include an opening through which one or more needles 5a-5c housed in needle housing I can protrude (seen in Figures 1 B-i H). The opening may be configured so as to align with a region of tissue or with an alignment template, as discussed further below. The distal end may be completely open, or may be partially covered. For example, the distal end may be partially covered and include one or more smaller openings dimensioned so as to allow one or more needles to pass through the distal end of needle housing 1.

[035] Needle housing 1 may have any suitable dimension for housing one or more needles. Needle housing I is shown in Figure IA having a cylindrical shape, but one of skill in the art will recognize that needle housing 1 may have any suitable shape, for example, rectangular, oval, conical, etc. Needle housing 1, and indeed, other parts of device 10, may be formed of any suitable material, for example, plastic, glass, metal, ceramic, or any combination thereof.

[036] Needles 5a-5c may be held in place inside needle housing 1 by a needle holder 4, shown in Figures 1A-1H. Needle holder 4 may be dimensioned so as to fit in an interior portion of needle housing I. Needle holder 4 may include one or more openings or projections configured to receive and retain needles 5a-5c. Needles ba-Sc may be held in needle holder 4 through any suitable means. For example, needles 5a-Sc may shape-lock into needle holder 4 through, e.g., a bayonet-style connection, a specific part attached to needles 5a-5c and configured for locking, a snap-fit connection, or the needles may screw into place. Further, needles Sa-5c may frictionally lock into needle holder 4, e.g., through the use of high-friction materials, sideways screw systems, comparatively harder materials having small holes for receiving the needles, adhesives, etc. Needles 5a-5c may be preloaded into needle holder 4. For example, needles 5a-5c may be cast in any suitable material, for example, a plastic -like a thermoplastic -or rubber. Needles 5a-5c could also be permanently fixed into other materials, including, e.g., ceramic or metal. In some embodiments, needles 5a-5c may be removable from needle holder 4, while in others, needles 5a-5c may be permanently affixed to needle housing 4. In some embodiments, a user may have the option to load different numbers or types of needles into needle housing 4 depending on the size or type of treatment needed or the size of the target area, for example.

[037] Needle holder 4 may hold needles 5a-5c in any suitable arrangement, e.g., in concentric circles, evenly around a center needle, or scattered across needle holder 4. There may be any suitable distance between the needles, and additionally, the distance may vary in certain embodiments to allow for loading of different numbers or types of needles. Further, while Figures 1A-1E depict either 2 or 3 needles, needle holder 4 may contain any number of needles, for example, one needle or 4 or more needles.

[038] Needles 5a-5c may include any suitable type of needle. Turning briefly to Figure 4, embodiments 37a-37g depict some of the many different types of needles that may be used in device 10. Further, in some embodiments, more than one type of needle may be loaded or preloaded into needle holder 4 of device 10. One or more needles may be a standard needle 37a with a conical point, or a hollow trocar needle 37c. One or more needles may be hollow and may have a closed distal or proximal end. Suitable needles may also include substantially parallel ridges or depressions forming a screw-like needle embodiment. These ridges or depressions could be any suitable height or depth and may be spaced any distance apart. In some embodiments, the distance between the ridges or depressions may vary. The screw-like pattern may extend over a substantial length of the needle, as shown in 37c, or may extend over only a portion of the needle, as shown in 37d. One or more needles in device 10 may also include a cutting needle 37e, having a tip shaped for cutting through tissue or similar materials. For example, cutting needle 37e may include blades designed as scalpels, which may be razor sharp. As is shown in the different exemplary embodiments of 37e, a tip 38, 38' of 37e may have two or more faces that meet each other along sharp edge portions. Further, one or more needles in device 10 may include multiple aspects of the embodiments displayed in 37a-37e. For example, a cutting tip needle may also include a screw-like portion.

[039] Needles in device 10 may be made of any suitable material. For example, the needles may be made of glass, plastic (with or without fillers, e.g., liquid silicone rubber, polyetheretherketone, polyphenylsulfone, polycarbonate, and/or polyoxymethylene), ceramic, metal (e.g., types of stainless steel, titanium, nitinol), or any suitable combination of materials. As 37f depicts, the needles may include more than one type of material. For example, the tip portion and the base portion of a needle may be comprised of two different materials. In some embodiments, the tip may be formed of a material that is harder than the base portion of the needle. In other embodiments, the entire needle may be formed of the same material. Additionally, needles may include any suitable coating, or any suitable combination of coatings. For example, a coating may be lubricious, drug eluting, anticoagulant, antiseptic, anesthetic, etc. The needle may further be filled with an obturator during insertion of the needle into the patient to increase the stiffness of the needle temporarily. For example, the needle may be filled with a material, such as tungsten, stainless steel, spring steels, or any suitable material or alloy thereof, to block an opening in the needle as it is introduced to the body. The needle may be monolithically formed, or alternatively, the needle may be formed of separate parts made of the same or different materials, for example, plastic-coated glass needles.

[040] The needles for device 10 may be configured so as to optimize use and/or patient comfort. For example, the needle design may decrease the amount of force needed to penetrate the skin, or to decrease the amount of force transferred to the skin from the needle. In some embodiments, the use of multiple needles may decrease the amount of force needed to penetrate the skin.

[041] Returning to Figures 1A-1H, as mentioned above, device 10 may also include a plunger 2. In certain embodiments, plunger 2 may assist with deploying needles 5a-5c from needle housing 1. For example, Figures lA-i B depict a hand-operated embodiment. Plunger 2 may project from a proximal end of needle housing I through an opening in housing 1, and may be operably coupled to needle holder 4 within needle housing 1. Plunger 2 and needle holder 4 may be integral or of one-piece construction. Plunger 2 may be configured so that when a user applies pressure to plunger 2, plunger 2 pushes down on needle holder 4 and causes needle holder 4 to slide distally inside needle housing 1. This causes needles 5a-5c to be pushed in a distal direction and to exit the distal opening of needle housing 1. In such an embodiment, plunger 2 may further include one or more depth indicators 3 (shown in Figure 1A). Depth indicator 3 may include one or more markings (e.g., radiopaque and/or sonoreflective markings) on plunger 2. When a user presses plunger 2 and causes plunger 2 and needle holder 4 to move distally within needle housing 1, depth indicator markings 3 on plunger 2 may allow a user to determine the distance that plunger 2 has been depressed by observing how many markings may still be viewed projecting from a proximal region of needle housing 1. In this manner, the user may be able to determine insertion depth of needles 5a-5c.

[042] Further, needle housing 1 may include one or more safety stops in either a distal or proximal region to prevent plunger 2 from being depressed past a certain amount to control a maximum insertion depth for needles 5a-5c. In some embodiments, such a stop may be fixed and preset, while in other embodiments, a user may be able to vary the insertion depth either prior to or during actuation of plunger 2. Varying the insertion depth may be done manually by a user, or may be programmably controlled or automatically controlled by an algorithm or application included in a controller. In still other embodiments, plunger 2 and needle holder 4 may be configured so as to increase resistance to pushing as plunger 2 is depressed further by a user. This may protect against over-deployment of needles 5a-5c and/or may slow the needle insertion rate as needles 5a-5c project further into body tissue, and presumably, closer to a target area to prevent over-shooting the target.

[043] In the embodiment shown in Figure IC, device 10 may further include a rotating cuff 7. In this embodiment, plunger 2 may include substantially parallel screw-like ridges or depressions. These ridges or depressions may be of any suitable height or depth and may be spaced any distance apart. In some embodiments, the distance between the ridges or depressions may vary. The screw-like pattern may extend over a substantial length of plunger 2, as shown in Figure 1 C, or may cover only a distal region portion of plunger 2. Figure 2B illustrates a more detailed depiction of the rotating embodiment. For example, rotating cuff 7 may further include a rotation-enabling mechanism to aid in rotation. In Figure 2B, a gear system 20 assists rotation of plunger 2, and correspondingly, the needles housed in needle holder 4. Gear system 20 shown in Figure 2B is an exemplary epicyclic gear system, but any suitable gear system or rotation assistance mechanism may be used.

[044] In this embodiment, a user may rotate rotation cuff 7 to deploy needles 5a-5b. To aid rotation by a user, rotation cuff? may include ridges or grips on an outer surface for engaging by a user. As a user rotates rotation cuff 7, a central region of rotation cuff 7, through which plunger 2 passes, may engage the screw-like ridges or depressions on plunger 2 and move plunger 2 distally or proximally, depending on the direction of rotation. Because plunger 2 may be operatively coupled to needle holder 4, this will consequently push or pull needle holder 4 and needles 5a-5b in a proximal or distal direction.

[045] In the embodiment shown in Figure 1 D, device 10 may not include plunger 2. Instead, needle holder 4 may include one or more slide grips 8, 8' projecting out of one or more walls of needle housing 1. Slide grips 8, 8' may pass through needle housing 1 and operably connect to needle holder 4. Needle housing 1 may further include one or more elongated slots (not shown) running in a distal-to-proximal direction into which one or more slide grips 8, 8' may be aligned. In this embodiment, a user may engage slide grips 8, 8' and move slide grips 8, 8' in either a proximal or distal direction to move needle holder 4 and needles 5a-5c in a proximal or distal direction. To aid in moving slide grips 8, 8', one or more of slide grips 8, 8' may include ridges or gripping aids located on an outer surface. Alternatively, a slide cuff (not shown) or slide lever (not shown), or any suitable grip means, may be used in place of slide grips 8, 8'.

[046] In the embodiment depicted in Figure 1 E, needles 5a-5c may be deployed from needle housing I via electromagnetic means. One or more magnets 12, 12' may be located on needle holder4 and/or a distal region of needle housing 1. In this embodiment, device 10 may also include a power source, for example, a battery, for controlling magnets 12, 12'. By causing the magnets to either repel or attract one another, needle holder 4 and needles 5a-5c may be moved in either a proximal or distal direction.

[047] Figure 1 F depicts a pneumatically or hydraulically controlled embodiment in which needles 5a-5c are deployed by pressure, for example, fluid pressure such as air pressure. Device 10 may include a connector 13 at a distal region. Connector 13 may allow for connection with a fluid source 16. Fluid source 16 may be capable of increasing the pressure in a distal region of needle housing 1 such that needle holder 4 is pushed in a distal direction. Alternatively, fluid source 16 may be capable of decreasing the pressure in needle housing 1, perhaps to a negative pressure, e.g., creating a vacuum, in order to move needle holder 4 in a proximal direction, retracting needles 5a-5cfurther into needle housing 1. In this embodiment, device 10 orfluid source 16 may further include a pressure gauge readable by a user. In another embodiment, fluids may be used to control the depth of the needles. For example, different volumes of fluid may be inserted into needle housing 1. The different volumes may cause corresponding displacement of the needles from or into needle housing 1.

In some embodiments, a noncompressible fluid may be used. In other embodiments, a compressible fluid, like water, may result in a different displacement-to-volume ratio.

[048] The embodiments depicted in Figures 1 G and 1 H show a spring-operated embodiment. In these embodiments, device 10 further includes a spring 19 surrounding plunger 2 in an interior region of needle housing 1 between a distal wall of needle housing I and a distal surface of needle holder 4. Spring 19 may be configured to bias needle holder 4 in a retracted position, such that pushing on plunger 2 overcomes the resistance of spring 19 and deploys needles 5a-5c from needle holder 1.

Spring 19 may alternatively press against needle holder 4 so as to bias needle holder 4 in a deployed position, in which case plunger 2 may be pulled to retract needle holder 4 and needles 5a-5c. Instead of, or in addition to plunger 2, a slide ring or slide grips 8, 8', configured similar to the embodiment discussed in relation to Figure 1 D, or rotation cuff 7, as shown in Figure IC, may be used to activate deployment. For example, Figure 2A shows a more detailed depiction of the spring-controlled deployment means.

A slide cuffS may be configured to slide proximally and distally along a slit 3 running in an axial direction on needle housing 1. Cuff 6 may be operably connected to needle holder 4 so that when a user slides cuff 6, needle holder 4 (inside needle housing 1) and a plurality of needles (shown as 5a-5g) are moved in a proximal or distal direction.

In this embodiment, device 10 may also include a rotating cuff 14. Spring 19 may be situated between rotating cuff 14 and needle holder 4 connected to sliding cuff 6 so that when a user rotates rotating cuff 14, spring 19 is released from a compressed state.

[049] As shown in Figure IG, device 10 may be entirely controlled by spring operation, oras shown in Figure 1H, device 10 may be partially controlled by spring operation and partially controlled by one of the other means discussed above, for example the plunger, rotation, or slide embodiments shown in Figures lA-iC. In such embodiments, one deployment means may be used to deploy needles 5a-5c far enough from needle housing I to penetrate the skin, while another deployment means may be used to control needle insertion once inside the body. In the embodiment shown in Figure IH, spring-controlled deployment is used to deploy needles 5a-5c far enough to puncture the skin, while the plunger-pushing deployment means described in reference to Figures IA-lB is used to control needle injection once needles 5a-5c have punctured the skin.

[050] In still other embodiments (not shown), needles 5a-5c may be deployed from needle housing I though the use of hydraulics, electronics/robotics, or any other suitable mechanism. Additionally, as described above, one or more deployment mechanisms may be used in a single device 10. Further, in all embodiments, the deployment system may include one or more lock mechanisms to prevent over-deployment and/or over-injection of needles 5a-5c. This mechanism may allow a user to preset a needle deployment depth, which may be adjusted, either prior to or during deployment, or may be fixed. Such depth-control mechanisms may include one or more stoppers, ridges, pressure increasers, springs, or any other suitable means for slowing or preventing distal movement of plunger 2, needles 5a-5c, and/or needle holder 4.

Additionally, needle housing 1, plunger 2, or any other region of device 10 may include depth indicators to indicate to a user how far needles 5a-5c have been deployed from needle housing 1. The deployment means and device 10 may also be configured so that absent user activation, needles 5a-5c are retracted inside needle housing 1 in order to protect both the patient and the user from needle sticks.

[051] Further, in any of the described deployment means, device 10 may further be configured to deploy all or less than all of the needles held in needle housing 4 at the same time. For example, Figure 3A depicts a intake unit 25 positioned at a distal region of needle housing I that allows less than all of the needles held in needle housing ito be deployed at once. A distal opening of needle housing 1 may be open, or alternatively, may be partially covered, and instead of one large opening, may have a plurality of smaller openings 26. In another embodiment, a region proximal to the distal opening in needle housing 1 may be partially covered and may include openings 26 through which needles in needle housing I may pass. As shown in Figure 3A, these smaller openings 26 are positioned in a ring around a central opening, however, any size, number, and orientation of openings 26 may be used.

[052] Intake unit 25 includes one or more openings 27. Intake unit 25 is located distal to openings 26. A polarity of needles (not shown) may be positioned in the one or more openings 26, but intake unit 25 may only allow propelling fluid pressure, e.g., air pressure, to pass through the openings 26 that are aligned with the intake opening(s) 27. Additionally, intake unit 25 may be rotatable. By rotating intake 25, opening(s) 27 will align with multiple needle openings 26, resulting in less than all needles being deployed from needle housing I during deployment. This may allow a user to move the location of opening 27 and adjust which needle or needles will be allowed to pass through opening 27. To allow rotation of intake unit 25, fluid pressure, for example air pressure, or any other suitable method can be utilized. In some embodiments, rotating intake unit 25 may include one or more grip portions 28 to aid manual rotation by a user.

[053] Thus, the presence of intake unit 25 may result in less than all needles being deployed from needle housing I during deployment. Additionally, intake unit 25 may be rotatable. This may allow a user to move the location of opening 27 and adjust which needle or needles will be allowed to pass through opening 27. To aid rotation by a user, rotating intake unit 25 may include one or more grip portions 28.

[054] Referring to Figure 3B, one or more needles may be deployed separately or may be permanently deployed from needle housing 1. For example, Figure 3B depicts a central guide needle 24. Guide needle 24 may be deployed free hand, or a user may deploy guide needle 24 with the guidance of an external device, such as an imaging device, e.g., with ultrasound or magnetic resonance imaging technology, to help view the location and/or depth of guide needle 24. This guide needle 24 may be separately deployed, for example, through an opening 27 in a intake unit 25, as shown in Figure 3A. Alternatively, intake unit 25 may have a central opening 27 in addition to other openings 27 in intake unit 25, so that intake unit 25 always allows guide needle 24 to pass through the center, even if intake unit 25 is rotatable, because even when intake unit 25 is rotated, a central opening 27 will remain centered. Any suitable means may be used to allow guide needle 24 to deploy separately or to stay continuously in a deployed state. Alternatively, guide needle 24 may be deployed in the same manner and at the same time as any other needle in needle housing 1. Guide needle 24 may allow a user to align needle housing I, containing one or more needles, on an injection site. In this manner, guide needle 24 may dictate the insertion depth, position, and/or angle of insertion of the other needles in needle housing 1. Further, guide needle 24 may include one or more depth indicator marking 3 to indicate the depth of needle deployment or injection. In the embodiment in Figure 33, guide needle 24 is shown as a central needle surrounded by a plurality of needles 5a-5g in needle housing 1. In other embodiments, guide needle 24 may be the only needle housed in needle housing I, or may be housed with any number of needles. Further, while guide needle 24 is shown as the center needle, guide needle 24 may be positioned off-center in needle housing 24.

[055] Furthermore, injection applicator device 10 and the deployment mechanisms used may be configured to insert one or more needles in any manner of ways. For example, in addition to the deployment mechanisms described above, the needles may be configured to deploy according to one or more needle insertion modes.

For example, one or more needles may be configured to allow for translation, rotation, or pulsation, for example, during insertion. Figure 4 depicts an exemplary needle rotation cuff 35 that may allow the individual needles in needle holder 4 to rotate during deployment. For example, as a user rotates needle rotation cuff 35, perhaps in conjunction with the rotation deployment embodiment described above, external rotation cuff 35 may in turn rotate one or more internal rotation gears 36 located inside of needle rotation cuff 35. Each rotation gear 36 may surround the base of a needle such that when the rotation gears 36 rotate, the corresponding needles also rotate. In some embodiments of the present disclosure, multiple different insertion modes may be used simultaneously, for example, the needles may be inserted in a pulsing, reciprocating motion while also rotating or translating. Alternatively, different modes may be used in sequence, for example, the needles may be configured to rotate while piercing the skin and then pulsate when inserting deeper into the tissue towards the target area. In other embodiments, only one insertion mode may be used during the entire deployment process or for a portion of the deployment process.

[056] In addition, different deployment and insertion speeds may be used. The same speed may be used throughout needle deployment and insertion, or different speeds may be used at different deployment or insertion times. For example, one or more needles may be deployed at a relatively higher speed initially to penetrate the skin, but then may reduce speed to penetrate the target area. In other embodiments, one or more needles may deploy at different speeds. For example, a guide needle 24 (Figure 3B) may deploy more quickly than the surrounding needles, or the guide needle may deploy slowly, and once fully deployed, the surrounding needles may quickly deploy around the guide needle. Any combination of needle deployment mechanisms, needle insertion modes, needle types, and/or deployment speeds may be used in combination with each other. Furthermore, needle deployment and/or insertion modes may be programmable and automatically controlled by any suitable logic controller and or CPU, using, for example, any suitable algorithm or set of algorithms. Alternatively, needle deployment and/or insertion modes may be manually controlled by a user.

Needle Positioning and Fixation [057] Another aspect of the present disclosure relates to the positioning and attachment of injection applicator device 10 relative to the body so as to promote accurate insertion depth, angle, and location. This may be achieved through a variety of embodiments and configurations. For example, device 10 may be connected to the body using one or more straps configured to wrap around a portion of the body. The strap may fit over a portion of the body, for example, it may be elastic or may tighten.

Alternatively, the strap may fasten, e.g., with Velcro®, laces, snaps, buttons, hooks, zippers, oranyothersuitablefastening mechanism. In otherembodiments, device 10 may be held to the body with adhesives, such as tape or glue, that may be applied over device 10 or between the body and device 10, or a portion of device 10. For example, double-sided tape may be used at a distal region of device 10. Adhesives may fix device 10 to the body and keep device 10 in contact with the body as the needles are inserted. Additionally, one or more templates may be used to attach device 10 to the body. A template may directly connect device 10, or the template may be connected to a holder or a frame. Such embodiments may be useful for certain procedures or diagnostics, such as those used with prostate cancer. Device 10 and/or a template or holder may align through the use of corresponding indentations and projections. For example, one or more indentations on device 10 may match up with one or more projections on a template, allowing device 10 to lock into position on the template, or vice versa. Any attachment mechanism described herein may be adjustable, allowing device 10 to lock in place at different angles or locations on a template or holder.

Additional positioning and attachment embodiments are depicted in Figures 5A-15.

[058] Referring to Figures 5A-5C, device 10 may be positioned and attached to the body of a patient using a pneumatic or vacuum pressure system. In this embodiment, device 10 may include a suction cap 40 at a distal end of device 10.

Suction cap 40 may form an airtight seal around a distal region of needle housing I and may extend outwards from needle housing 1, creating a hollow space between the inner walls of suction cap 40 and the outer walls of needle housing 1. A flexible, sealing member disposed on an edge of suction cap 40 may assist with forming a seal. Suction cap 40 may be formed monolithically with needle housing 1 or may be a formed of a separate piece. Suction cap 40 may be removably or permanently attached to needle housing 1 and device 10. Suction cap 40 may extend distally so as to end at an opening that is flush with the distal end of needle housing I or may extend more distal than needle housing 1. Suction cap 40 may have an opening at its distal end configured for positioning on the body of a patient so as to create an airtight seal with the body. As is shown in Figure 5C, suction cap 40 may be used in conjunction with a spring 42 that biases suction cap 40 in a distal position. This may allow suction cap 40 to form and/or maintain a tighter seal with the body.

[059] Device 10 may be connected to a fluid pressure device, or may itself contain a fluid pressure device configured to create a vacuum in the open space inside suction cap 40, between needle housing 1, and the body. This suction may allow device 10 to be held in position on the body so that needles 5a-5c may be deployed at a set location. The suction also keeps device 10 in contact with the body as the needles are inserted. Further, this arrangement may control for patient movement, because even if the patient changed positions, the suction would allow device 10 to move relative to the patient and maintain consistent relative location.

[060] In another embodiment, shown in Figure 6A, device 10 may be aligned on the body via a flap template 44. Flap template 44 may be directly fitted on the body.

Flap template 44 may be attached to the body using suction, adhesive, or any other suitable mechanism. Flap template 44 may have alignment regions configured to align with a distal portion of needle housing I, suction cap 40, and/or one or more needles, for example a guide needle, in needle housing 1 to help a physician align and orient device 10 onto the body. A physician may align flap template 44 so that the alignment regions correspond to a target insertion area. Flap template 44 may be easy to adjust and align. Once in place, the alignment regions may help hold device 10 in place during needle deployment and insertion. Flap template 44 may be flexible and/or may be capable of forming to the contours of a patient's body. Flap template 44 may include any suitable alignment regions, for example, visual markings, depressions, projections, or snap-fit, andfor screw-fit regions that device 10 may lock into.

[061] In the embodiment of Figure 63, a corset or shirt-like body template 48 may be fitted over a patient. Body template 48 may offer greater precision and stability by fitting tightly against the body to hold a larger portion of the body in place and hold device 10 steady relative to the body. Body template 48 may be fitted over the head of a patient, or may include an opening in a back, side, or front portion of body template 48. For example, one or more hook and eye closures, hook and loop closures (e.g., Velcro®), zippers, laces, straps, or any other suitable means, may allow a patient to open and close a portion of body template 48 to facilitate dressing, removal and positioning of body template 48.

[062] Body template 48 and flap template 44 may be made of one or more elastomeric or flexible materials, for example, rubber, spandex, silicone, or other suitable synthetic or natural fibers or materials. Alternatively body template 48 and flap template 44 may be formed of a non-elastic material, like, e.g., hard engineering plastic, non-elastic cloth, or a sticker-like adhesive arrangement with adhesive applied to, e.g., one or more sides of paper or cloth. While flap template 44 is depicted as a rectangular flap dimensioned to cover a portion of breast 32, flap template 44 may be any suitable shape or size and may be configured to attach to any region of the body. For example, flap template 44 may be circular, oval, or irregularly shaped, and may be small enough to lie flat against a smaller body region, such as a toe or wrist, or large enough to fit over a larger region, such as the abdomen or back. Additionally, while body template 48 shown in Figure 6B is configured to fit onto the upper torso, body template 48 may be dimensioned and shaped so as to fit onto any area of the body, for example, body template 48 may be configured as an arm or leg band or sleeve, a glove or sock, an abdominal band, shorts or pants, or any other suitable configuration.

[063] Figure 60 shows yet another embodiment of the present disclosure. In this embodiment, needle housing 1 includes one or more flaps 45a-45c, located at a distal region of needle housing 1. Flaps 45a-45c may be attached to needle housing 1 on one end and configured to attach to the body so as to hold needle housing 1 of device 10 in position. Flaps 45a-45c may attach to the body via adhesive, suction, or one or more straps configured to wrap around a portion of the body. Flaps 45a-45c may be plastic, such as a thermoplastic, rubber, cloth, silicone, etc. They may be adhesive on one or both sides. Flaps 45a-45c may also be used in conjunction with tape or other adhesive fitting over the flaps or over the full device. Further, in some embodiments, needle housing I may itself have adhesive on a distal end region configured to contact and adhere to the body. This adhesive and/or the flap adhesive may be absorbable with a fluid, for example, water-soluble, or not. While shown as rectangular tabs, 45a-45c may come in any suitable shape, orientation or size. Further, any suitable number of flaps 45a-45c may be used. In one embodiment, one flap may be configured to extend along the entire circumference of needle housing 1.

[064] In other embodiments, device 10 may be positioned on the body while not attaching to, or perhaps not even directly contacting the body. For example, device may be held in place by a frame 50 attached to a table clamp 51 (Figure 7) moveably, detachably, or permanently mounted on a table 52 to hold device 10 in place.

Frame 50 may be adjusted and positioned so as to align device 10 over a target area on the body. Further, frame 50 may include any suitable locking mechanism to keep frame securely in position once the correct angle and orientation for device 10 has been achieved. For example, the locking mechanism may be a friction locking mechanism, a spring locking mechanism, a gear locking mechanism, a ratcheting mechanism, or any other suitable mechanism. Each joint of frame 50 may have its own locking mechanism and may be able to affect the angle at which device 10 is held. In this manner, a user may accurately control the location and angle of device 10 relative to the patient.

Further, table 52 may include one or more position markers 53 to assist a user when adjusting and positioning frame 50. For example, if a patient were laying on table 52, position markers 53 could help a user measure a certain distance from an anatomical landmark as dictated by, for example, an image of a tumor or other target area. In alternate embodiments, frame 50 may clamp onto other devices, for example, a surgical tray or stand, a chair, a physician's body, a patient's body, or frame 50 may be freestanding, resting on a piece of furniture or mounted on a floor stand.

[065] An advantage of frame 50 is that the weight of the orienting holder mechanism and device 10 may be transferred from the patient and/or the user to frame 50. Further, unlike a user or a patient, frame 50 may keep perfectly still for an extended period of time. Under some circumstances, frame 50 may be capable of achieving more constant and precise positioning and angling of device 10. In some embodiments, frame 50 and/or clamp 51 may be capable of tracking, following, and/or adjusting to the movement of the patient's body, e.g., breathing or twitching, to maintain proper positioning relative to the body and keep device 10 on target.

[066] Device 10 may further include a connector portion situated on any number of the positioning embodiments discussed above to further orient and/or attach device 10 to the body. For example, Figure 8 depicts an attachment mechanism 63, similar to flap template 44 discussed in regards to Figure 6A, that attaches to the body, for example, using any of the attachment mechanisms described above. Attachment mechanism 63 may also include a connector template 61 configured to mate with a distal region of needle housing I ofdevice 10. Connectortemplate6l mayconnect with device 10 by screwing or twisting in place, by friction or snap fitting in place, by aligning male and female projections or insertions located on either or both of connector template 61 and device 10, or any other suitable means. For example, Figure 11 B depicts an attachment mechanism 63 including an exemplary connector template 80.

Connector template 80 includes one or more ridges or threadings 85 on an outer surface that are configured to allow an internal surface of needle housing ito snap-fit, screw-fit, clasp, or friction-fit into place, securing device 10 to connector template 80.

Indeed, an inner surface of needle housing 1 may have corresponding ridges or threading to further enable the attachment of device 10 to connector template 80.

Returning to the exemplary embodiment shown in Figure 8, connector template 61 includes alignment holes 62 that may align with the arrangement of needles in needle housing 1. Needle housing 1 of device 10 may orient with connector template 61 by twisting and locking into position such that the alignment holes of connector template 71 and the needles arranged in needle housing 1 align, allowing the needles to pass through the alignment holes and into the body when deployed.

[067] Figures 9A and 9B illustrate other template embodiments configured to position a portion of the body between two adjustable brackets 72, 72'. Adjustable brackets 72, 72' of template 70 may be positioned around a portion of the body, for example, a breast or an arm, or, alternatively a portion of the body may be inserted into a stationary template 70. Once in place, adjustable brackets 72, 72' may be brought closer together so as to restrict movement of the positioned tissue, and in some cases, to squeeze the tissue into place, so as to flatten the tissue and/or substantially prevent it from moving. Adjustable brackets 72, 72' may be brought closer to one another or spread apart via bracket adjustment mechanism 73. Bracket adjustment mechanism 73 may include a screw-like structure that can be rotated clockwise or counterclockwise to move adjustable brackets 72, 72' closer together or farther apart. Bracket adjustment mechanism 73 may include any suitable tightening mechanism known in the art. For example, bracket adjustment mechanism 73 may consist of a rod connecting adjustable brackets 72, 72'. The rod may have a plurality of openings along its length, and one or both of the adjustable brackets may include a depressible projection that can be depressed to move the adjustable bracket along the length of the rod, or released to lock into one of the plurality of holes in the rod to secure the adjustable brackets 72, 72' in place.

[068] Adjustable brackets 72, 72' may include one or more openings dimensioned to receive a distal end of device 10. Device 10 may adjustably couple to template 70 so as to allow a user to position device 10 into an opening of template 70 at more than one angle relative to the template. In one embodiment, template 70 may be configured to optionally lock device 10 into place at different angles. Once template 70 is adjusted and brackets 72, 72' are in place, a user may align device 10 within the opening in template 70 and either hold device 10 in place, or alternatively, lock device in place using any of the exemplary mating or locking mechanisms described above, or any other suitable means. Once device 10 is in place, both the tissue and device 10 are secured and the needles in device 10 may be deployed at a consistent angle, location, and depth relative to the body.

[069] Template 70 may be positioned either vertically or horizontally, as show in Figures 9A and 9B, respectively, or in any other orientation. Alternatively, template may not be mounted and may be positioned freely in any manner on the body.

Device 10 may be made of any suitable material, for example, metal or plastic, and may come in a variety of dimensions so as to fit around any body part, for example, a breast, arm, leg, or abdomen.

[070] In another embodiment, the template of Figure 9A may include only a single bracket 72. In this embodiment, a band, a strap, or another suitable holding device may retain a portion of the body against template 72. Such a configuration may be useful for certain diagnostic procedures or treatments, such as those for the prostate.

[071] Figure 10 illustrates an exemplary disclosure of a template configured as an article of clothing. Although Figure 10 depicts the article of clothing as a brassiere (bra) 76, those of ordinary skill in the art will recognize that the template may be configured as any suitable undergarment or outerwear. Bra template 76 may be configured so as to be positioned over the chest area, and may wrap around both the chest area and the back area of a patient. Bra template 76 may include any of the materials or closure/orienting mechanisms described above in reference to flap template 44 and body template 48, or any other suitable materials and/or closure mechanisms. Bra template 76 may have straps, as shown in Figure 10, or may alternatively lack straps. Bra template 76 may further include one or more alignment holes or projections configured to mate or match up with a distal portion of needle housing 1 of device 10. Device 10 may connect to bra template 76 or be held in place on bra template 76 according to any of the methods described above, for example, a connector template, suction cup, adhesives, Velcro®, etc. or any other suitable mechanism. As is shown in Figure 10, openings in bra template 76 may be sized and configured so as to apply pressure to one or more needles from device 10, holding the needles in place. A template configured for wearing may be formed of any suitable material, for example, a cloth or mesh, and may be formed of any suitable elastic or non-elastic material.

[072] In another series of embodiments, a connector template 80 may be configured to receive one or more needles, which may then be connected to an afterloader, as shown in Figure 1 1A. Connector template 80 is connected to the body via attachment mechanism 63. Needle housing 1 may attach to connector template 80, and connector template 80 may receive the needles contained in needle housing 1.

Once connector template 80 is connected to needle housing 1, the needles may be expelled from needle housing 1 and inserted into connector template 80. Because needle housing 1 is connected to the body via connector template 80 and attachment mechanism 63, the body is held in position while the needles are inserted.

[073] Once the needles are inserted into the body to a predefined depth, needle housing I is detached from connector template 80. Needle housing I is then pulled backwards, away from connector template 80, which causes obturators located in the needles (Figure 2B, Element 21) to be pulled out of the hollow needles (Figure 2B, Element 22), while the hollow needles are held in place by connector template 80. At this point, transfer tube holder 81 can be connected to connector template 80, and may therefore allow the inserted needles to be connected to the afterloader in one movement. Figure 1 1A provides an exemplary view of hollow needles 82 held in place on connector template 80 as a transfer tube holder 81 is about to be connected. Device and connector template 80 may be suitable for use with any type of afterloader, for example, Flexitron® or M-selectron® afterloaders.

[074] Figure 15 shows another embodiment in which a trocar connector template 101 may include one or more needles or trocars 103a-103d protruding into the skin while attached to the body via an attachment mechanism 63. In this embodiment, hollow needles or trocars are configured so as to project through the skin of a patient.

Device 10 is then aligned so that alignment openings 102 in trocar connector template 101, which communicate with the inner lumens of the one or more hollow needles or trocar tips 103a-103e, align with the arrangement of one or more needles housed in needle housing 1 of device 10. Accordingly, when needles in device 10 are deployed, they enter corresponding alignment openings and pass through the corresponding trocar tips or hollow needles and into the tissue. This embodiment may help, for example, reduce the amount of force needed to insert the one or more needles into the body, because trocar tips 103a-103d or the hollow needles may have already punctured the skin. This pre-puncturing embodiment may also result in more precise placement of the needles into the tumor.

[075] Figures 16A-16C, 17A-17D, and iSA-lOB depict an alternative pre-puncture embodiment. As is shown in Figure 16A, a connector template 200 may be affixed to the body of a patient in any one of the suitable ways previously discussed.

Connector template 200 may include one or more alignment openings 202 extending through connector template 200 from a surface contacting the body to a surface opposite the body. Connector template 200 may be any suitable shape or size or may be formed of any suitable material. Further, alignment openings 202 may be arranged in any suitable manner on connector template 200, e.g., evenly distributed, in a ring around the periphery, in a target pattern, in a rectangular or matrix arrangement, in a row, irregularly spaced, etc. [076] Pre-puncturing unit 204, shown in Figure l6B, may be configured to mate with connector template 200 and may include one or more piercing devices 206 extending from the surface of pre-puncturing unit 204 configured to mate with connector template 200. Piercing devices 206 may be oriented on pre-puncturing unit 204 in substantially the same pattern as alignment openings 202 are arranged on connector template 200, so that when pre-puncturing unit 204 mates with connector template 200, piercing devices 206 pass through alignment openings 202. Piercing devices 206 may be slightly longer than the thickness of connector template 200 so that piercing devices 206 pass through the entire length of alignment openings 202 and protrude from the opposite side. Accordingly, piercing devices 206 may be configured to puncture the skin underneath connector template 200. The thickness of connector template 200 and/or the length of piercing devices 206 may be selected to achieve any suitable pre-puncture depth.

[077] Piercing devices 206 may include any suitable sharpened object for piercing the skin, including hollow or solid needles, trocars, or scalpels, for example.

Once pre-puncturing unit 204 has mated with connector template 200 and piercing devices 206 have punctured the skin, as is shown by puncture marks 207 in Figure I 7C, puncturing unit 204 may be removed from connector template 200.

[078] Once pre-puncturing unit 204 has pre-punctured the skin underlying alignment holes 202 of connector template 200, a load cell 210 may be mated with connector template 200. Load cell 210 may include one or more needles 211 protruding from a surface of load cell 210 configured to mate with connector template 200. Needles 211 may be oriented on load cell 210 in substantially the same pattern as alignment openings 202 are arranged on connector template 200. Accordingly, when load cell 210 mates with connector template 200, needles 211 pass through alignment openings 202. Needles 211 may be longer than the thickness of connector template so that needles 211 pass through the entire length of alignment openings 202 and protrude from the opposite side. Accordingly, needles 211 may be configured to pass through the skin underneath connector template 200 and into the body to a pre-determined depth. The placement of connector template 200 on the body and the thickness of connector template 200 and/or the length of needles 211 may be selected to achieve any suitable treatment delivery location and depth.

[079] While the term needles is used, needles 211 may include any suitable needle, catheter, trocar, or treatment delivery structure. Further, less force may be needed to insert needles 211 into the body, because pre-puncturing unit 204 has already punctured the skin, creating puncture marks 207. This may expand the range of conduits and materials that may be used to form needles 211, because needles 211 do not need to puncture the skin themselves. This may also increase patient comfort during insertion and/or during treatment.

[080] Load cell 210 may mate with connector template 200 and may be configured to lock in place on connector template 200 via a snap-fit, friction fit, clasp, or any suitable connection mechanism. Once mated and locked in place, as is shown in Figure 17B, a transfer tube connection plate 212 may be brought in line with, mated with, and locked in place on load cell 210 via a snap-fit, friction-fit, clasp, or any suitable connection mechanism, as is shown in Figure 17C. Once secured in place, transfer tube connection plate 212 may be connected to an afterloader via transfer tubes 214, as shown in Figure 1 7D. Transfer tubes 214 may include any suitable guide tubes, e.g., catheters, trocars, or hollow needles. Once connected, an afterloader be configured to deliver suitable radiation treatment to the body. The treatment may pass through transfer tubes 214, transfer tube connection plate 212, needles 211, and into the body to a treatment location. Once a treatment session is completed, transfer tubes 214 may be removed from transfer tube connection plate 212, connection plate 212 may be removed from load cell 210, and load cell 210 may be removed from connector template 200. In some embodiments, connector template 200 may then be removed from the body.

[081] In other embodiments, connector template 200 may be allowed to remain on the body, for example, to maintain consistent alignment and location over a series of treatment sessions. If connector template 200 is to remain on the body, a cover 217 may be brought in line with connector template 200 (Figure 18A) and secured to template 200 (Figure 183). Cover 217 may provide protection for template 200 or the underlying pierced skin. Cover 217 may lock in place on connector template 200 in any suitable manner, e.g, snap-fit, screw-fit, clasp, or friction-fit. Additionally, in embodiments where connector template 200 is intended to remain on the body, connector template 200 may be configured to rotate on the patient without removing template 200 from the patient. For example, a center portion of connector template 200 may be rotated so that the alignment openings 202 are moved over different areas of the body. Rotating connector template 200 between treatment sessions may prevent repeated puncturing of the same location on the skin, which may in some instances cause scabbing, scarring, or soreness for the patient.

[082] Figure 13 portrays another exemplary embodiment of device 10. In this embodiment, a container 93 may have one or more body openings 96 and may be configured so as to surround a portion of the body. Container 93 may include one or more hinges 94 and may swing open so as to facilitate application or removal of container 93 from a portion of the body. Container 93 may also include a locking mechanism (not shown), e.g., a clasp, a hook, a latch, or other suitable device, to prevent container 93 from swinging open during use or during storage. Container 93 may be configured so as to surround a portion of the body, allowing the body portion to protrude into an inner region of container 93 through a body opening 96. Once inside container 93, device 10 may align with an alignment opening 91 in container 93. Thus, container 93 may be configured to hold both the body portion and device 10 in alignment so that device 10 may deploy one or more needles or catheters into the body portion at a specific location and orientation. Body openings 96 and alignment openings 91 in container 93 may be oriented anywhere on container 93 and may be located anywhere relative to each other.

[083] In other embodiments, needle housing 1 of device 10 may include an alignment mechanism 97 protruding distal to a distal-most end of needle housing 1. In the embodiment shown in Figure 14, alignment mechanism 97 may include an adjustable arm portion extending from a distal region of device 10 and an adjustable wall 95 extending perpendicularly from a distal region of alignment mechanism 97.

Alignment mechanism 97 may be configured to extend or retract relative to needle housing 1 and may correspondingly move adjustable wall 95 further from or closer to needle housing 1. For example, alignment mechanism 97 may be extended distally away from device 10 so as to maximize the space between adjustable wall 95 and the distal end of needle housing 1. As is shown in Figure 14, a portion of the body may be oriented between the distal end of needle housing 1 and adjustable wall 95. Alignment mechanism 97 may then be guided proximally, back towards the distal end of needle housing 1, so that the portion of the body in between is squeezed and held into place.

Thus, Figure 14 discloses another mechanism for aligning device 10 with a portion of the body for needle deployment and insertion.

[084] Device 10 may also include any number of safety mechanisms to prevent unintended deployment of needles from needle housing 1. For example, plunger 2 and a proximal region of needle housing 1 may include snap-fit, friction-fit, ratcheting, or screw-release safety mechanisms, or any other suitable safety mechanism for preventing unintended deployment of needles 5a-5c. As is shown in Figure 12, plunger 2 may include one or more teeth 90a configured to act as stoppers or to resist distal movement of plunger 2. A proximal portion of needle housing 1 may include a corresponding pawl-type mechanism 90b configured to resist sliding over teeth 90a, and thus to resist distal movement of plunger 2. This arrangement may be configured so as to require greater user effort in order to deploy needles 5a-5b, may require a user to release pawl 90b to a position biased away from plunger 2, or any suitable release or override mechanism. Other safety mechanisms may include proximal or distal stoppers to prevent accidental deployment or over deployment, removable needles for storage while not in use, or any suitable mechanism.

[085] Any of the mechanisms, or parts of device 10, including any needles, templates, flaps, or containers, may be disposable or reusable. Alternatively, disposable and reusable parts may be used together in one device 10. Further, any of the templates or connectors described above may be used to align and/or lock, device in place. In some embodiments, device 10 may only be secured in place when one or more needles are in a deployed state protruding from needle housing I and injecting into the template and/or skin and/or body tissue.

[086] During use, a physician may locate a target area, for example, using an imaging device displaying a real-time or a previously taken image. Using the image, device 10 is then positioned against the body, according to any of the exemplary embodiments described above, or any combination of exemplary embodiments, in a predefined location and at a predefined angle relative to the body. This may be done, for example, with the help of a template, connector, clamp, or guide needle (as shown in Figure 3B). Using the image, device 10 may be adjusted to set a predetermined injection depth so that one or more needles or catheters may be injected to the target area. Once injection application device 10 is in place, one or more needles or catheters are deployed from housing I using any of the disclosed deployment mechanisms or modes, or any combination of mechanisms or modes, and injected into the body towards a target area. In some embodiments, when device 10 is applied to the breast, needles and/or catheters may not penetrate the entire breast. In other embodiments, needles and/or catheters may penetrate, extend through, and emerge from the other side of the breast, as in some conventional forms of breast brachytherapy.

[087] The many features and advantages of the present disclosure are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the present disclosure that fall within the true spirit and scope of the present disclosure. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the present disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within

the scope of the present disclosure.

[088] Moreover, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be used as a basis for designing other structures, methods, and systems for carrying out the several purposes of the present disclosure. It is important, therefore, to recognize that the claims should be regarded as including such equivalent constructions insofar as they do not depart from the spirit and

scope of the present disclosure.

Claims

Claims What is claimed is: 1. An applicator for controlling the insertion of a plurality of needles into a body of a patient, comprising: a needle housing having a proximal region and a distal region; a needle holder slideably disposed within the needle housing and configured to retain the plurality of needles; a plunger operably coupled to the needle holder such that movement of the plunger moves the needle holder from the proximal region to the distal region of the needle housing; and a plurality of needles retained by the needle holder, wherein the plurality of needles are configured to transition between a retracted configuration wherein the needles are withdrawn within the needle housing and an extended configuration wherein the needles protrude from the distal region of the needle housing.
2. The applicator according to claim 1, wherein the distal region of the needle housing further includes a distal face having at least one opening through which at least one of the plurality of needles may pass.
3. The applicator according to claim 1, wherein the applicator is operably coupled to a treatment source and is configured to receive a treatment from the treatment source and deliver the treatment through the plurality of needles and to the body of the patient.
4. The applicator according to claim 3, wherein the treatment source is an afterloader and the treatment includes radiation.
5. The applicator according to claim 1, further comprising an alignment template configured to be positioned on the body of the patient, wherein the alignment template includes at least one opening and is configured to receive a portion of the needle housing, such that the plurality of needles pass through the openings in the alignment template when in the extended configuration and pass into the body of the patient.