WO2025217474A1 - Multi-head instillation device and methods of use - Google Patents

Abstract

Methods for treating a condition characterized by tunneling wounds and a multi-head delivery system adapted for simultaneous delivery of therapeutic agents to a plurality of proximal or adjacent wounds are described herein. The method includes using a multi-port catheter/cannula to simultaneously deliver a therapeutic agent to multiple adjacent wounds and instilling the therapeutic agent to the wounds.

Description

MULTI-HEAD INSTILLATION DEVICE AND METHODS OF USE

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to and any benefit of U.S. Provisional Application No. 63/633,078, filed April 12, 2024, the content of which is incorporated herein by reference in its entirety.

FIELD

[0002] The present invention relates to treatment systems for use in therapeutic wound care applications, and more particularly, to therapeutic agent delivery systems for instilling medication to a wound.

BACKGROUND

[0003] So-called tunnelling wounds (TW) are a chronic wound that has progressed to form a space underneath the surface of the skin. They are sometimes referred to as sinus tracts, fistulas, or channels. TWs can take a variable amount of time to heal, depending on the underlying disease, size, depth, and overall health of the person. It can take several weeks or months for deep tunneling wounds to heal.

[0004] Hidradenitis Suppurativa (HS) is a chronic inflammatory disease characterized by painful inflammatory skin nodules, abscesses and tunneling wounds. Current global estimates of prevalence for HS vary between 0.03% and 4%. HS is more common in females. Disease onset is often around late puberty into the third decade and second peak of prevalence occurs in the fifth decade. The disease has been associated with smoking, obesity, and hormonal fluctuations however, the cause for the disease remains unknown. Later in the disease there is dysregulation of the immune system and gut and skin dysbiosis have been characterized. Importantly, biofilms have been identified in HS TW, making treatment even more challenging. The disease can be readily diagnosed by dermatologists, however there is an overall diagnostic delay of 7-10 years from symptoms onset. Disease severity has been traditionally captured using the Hurley staging system that has 3 tiers referring to the absence of TW, the presence of TW in a single anatomical unit (e.g. axilla) with normal interlesional skin, and finally the third stage describes an entire anatomical unit devastated with TW and scarring. SUMMARY

[0005] The general inventive concepts are based, in part, on the recognition that conventional treatments for TW, including HS-associated TW, are ineffective and often require clinical administration of treatments in the tunnel’s space. For example, treatment of HS is often frustrating for patients and the current paradigm centers on medical therapies, psychosocial support, and various degrees of surgical removal of diseased skin. Currently, part of the standard of care for HS TW is a de-roofing procedure in which the skin above the tunnel is excised and the tunnel is then allowed to heal by secondary intention. This limited excisional technique is often preferred to wide local excisions since unaffected skin loss is minimized compared to other surgical excisions. However, the procedure is still invasive, associated with post operative pain, and intense wound care, and requires a number of weeks for recovery. Deroofing also results in a scar that extends the length of the original TW. Finally, de-roofing and other surgical methods are associated with of recurrence in about a third of patients. Therefore, there is a need to develop a minimally invasive, minimally scarring, well tolerated and simple method to treat and heal HS TW.

[0006] Various exemplary embodiments describe a multi-head delivery system for simultaneous delivery (e.g., instillation) of a therapeutic agent to a plurality of wound sites, wherein the system comprises a plurality of tubes. Each of the tubes include a distal end and a tip portion positioned on the exterior of the tube along a length of the tube, a rotatable portion, and a therapeutic agent insertion port. The rotatable portion connects the plurality of tubes to the therapeutic agent insertion port. The insertion port comprises a connection means for releasably connecting a therapeutic agent delivery device to the multi-head delivery system.

[0007] Various exemplary embodiments contemplate a method of simultaneously treating a plurality of tunneling wounds in an individual, wherein the method comprises providing a therapeutic agent delivery device with a predetermined amount of a therapeutic agent contained therein and a multi-head delivery system comprising a plurality of tubes, positioning a tube of the multi-head delivery system at individual tunneling wound sites, connecting the therapeutic agent delivery device and the multi-head delivery system in fluid communication with one another, and engaging the therapeutic agent delivery device to simultaneously deliver a therapeutic agent to each tunneling wound.

[0008] Various exemplary embodiments contemplate a kit for treating a tunneling wound characterized by multiple adjacent tunneling wounds, wherein the kit comprises a multi -head delivery system for simultaneously delivery of a therapeutic agent to a plurality of wound sites. The system comprises a plurality of tubes. Each of the tubes include a distal end and a tip portion positioned on the exterior of the tube along a length of each tube, a rotatable portion, and a therapeutic agent insertion port. The rotatable portion connects the plurality of tubes to the therapeutic agent insertion port. The insertion port comprises a connection means for releasably connecting a therapeutic agent delivery device to the multi-head delivery system; a therapeutic agent delivery device; a predetermined amount of a therapeutic agent; and at least one of syringe needles, sterilizing wipes, scissors, tweezers, a probe, gauze, tape, bandages, and instructions.

[0009] Other aspects and features of the general inventive concepts will become more readily apparent to those of ordinary skill in the art upon review of the following description of various exemplary embodiments in conjunction with the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[00010] The general inventive concepts, as well as embodiments and advantages thereof, are described below in greater detail, by way of example, with reference to the drawings in which:

[00011] Figure 1 shows a multi -head delivery system according to one exemplary embodiment.

[00012] Figure 2 shows customization of the length of tubes in a multi-head delivery system.

[00013] Figure 3 shows positioning and securing a multi-head delivery system for application of a therapeutic agent to an individual.

[00014] Figure 4 shows engagement of a therapeutic agent delivery device and simultaneous application of a therapeutic agent to multiple discrete tunneling wounds.

[00015] Figure 5 shows a multi-head delivery system according to the general inventive concepts wherein a cap has been positioned after administration of the therapeutic agent to the tunneling wounds.

[00016] Figure 6 shows a multi -head delivery system according to another exemplary embodiment.

[00017] Figure 7 shows a tube and tip portion of a multi -head delivery system according to another exemplary embodiment. [00018] Figure 8 shows a tube and tip portion of a multi -head delivery system according to another exemplary embodiment with exemplary dimensions for the tip portion.

[00019] Figure 9 shows an image of a multi -head delivery system according to another exemplary embodiment.

[00020] Figure 10 is an image of exemplary contents of an embodiment of a kit for treating one or more tunneling wounds.

DETAILED DESCRIPTION

[00021] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the embodiments belong. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the various embodiments, the preferred methods and materials are described herein. All references cited herein, including published or corresponding U.S. or foreign patent applications, issued U.S. or foreign patents, or any other references, are each incorporated by reference in their entireties, including all data, tables, figures, and text presented in the cited references. In the drawings, the thickness of the lines, layers, and regions may be exaggerated for clarity. It is to be noted that like numbers found throughout the figures denote like elements. The terms “system” and “inventive system” may be used interchangeably herein.

[00022] As used in the specification and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[00023] Unless otherwise indicated, all numbers expressing quantities of elements or components used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present exemplary embodiments. At the very least, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.

[00024] Unless otherwise indicated, any element, property, feature, or combination of elements, properties, and features, may be used in any embodiment disclosed herein, regardless of whether the element, property, feature, or combination of elements, properties, and features was explicitly disclosed in the embodiment. It will be readily understood that features described in relation to any particular aspect described herein may be applicable to other aspects described herein provided the features are compatible with that aspect. In particular: features described herein in relation to the method may be applicable to the delivery system and vice versa.

[00025] Every numerical range given throughout this specification and claims will include every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[00026] The terms “treating” and “treatment” as used herein, unless otherwise specified, includes delaying the onset of a condition, ameliorating or reducing the severity of symptoms of a condition, or eliminating some or all of the symptoms of a condition.

[00027] The term “an effective amount” is intended to qualify the amount of therapeutic agent which will achieve the goal of treating a disease (e.g., treating a tunneling wound), or that which will achieve the goal of decreasing the risk that the patient will suffer an adverse health event (e.g., recurrence of a tunneling wound), including reducing or preventing one or more symptoms, while avoiding adverse side effects such as those typically associated with alternative therapies. The effective amount may be administered in one or more doses.

[00028] The general inventive concepts relate to systems for and methods of treating a tunneling wound, including treating multiple tunneling wounds simultaneously by delivering/instilling a therapeutic agent.

[00029] While conventional cannulas, catheters and syringes may be suitable for application or instillation of therapeutic agents in less complicated wounds, they are not without drawbacks, such as lacking the ability to treat multiple wounds simultaneously. This is important in the context of TW, including HS associated TW as the condition often presents with several wounds in proximity to one another. Thus, there is a need for an improved delivery system that can address the specific needs of tunneling wound therapy, and especially HS TW, while providing ease of use for the patient.

[00030] The general inventive concepts contemplate a multi -head delivery system for simultaneously delivery of a therapeutic agent to a plurality of tunneling wound sites. Figure 1 shows an exemplary multi-head delivery system 100 according to the general inventive concepts. The multi-head delivery system comprises a plurality of tubes 110 (also referred to as catheters and cannulas), the tubes include a distal end 120 for insertion into a wound site and a tip portion 130, which may be comprised of silicone, santoprene, nylon, pellethane, pebax and the like. The size and shape of the tip portion are not necessarily limited, but are sized to conform to a wound site. In the embodiment shown in the figure, the tip portion is frustoconical, but those of ordinary skill in the art will recognize that other shapes are contemplated that also fall under the general inventive concepts. For example, the tip portion could take the form of a barbed-type plug or an inflatable micro balloon. So long as the tip portion is adapted to plug/engage with the wound to allow for instillation of a regular forward flow of therapeutic treatment while avoiding retrograde/backflow. In certain embodiments, the smaller end (e.g., the distal end) is ~3mm and expands out to ~6mm. This allows a small length of the tip to enter into the opening and then it will plug the tunnel when inserted an appropriate distance. The material of the tubes is not necessarily limited, but those of ordinary skill in the art will recognize that the tubes should be of medical or surgical grade plastics or rubbers, should be pliable and flexible to accommodate the contours of the patient’s body, and should be compatible with prolonged contact with human skin and not contribute to infection or irritation. Examples include, but are not limited to silicone, PVC, pellethane, etc. The length of the individual tubes may be customizable to individualize the delivery of a therapeutic agent to multiple wound sites simultaneously. In certain embodiments, the tubes have a length of e.g., 3-10 inches, though there is no upper limit. It is contemplated that a health care provider or the individual patient will cut to length as needed. In certain embodiments, the tube has an inner diameter of 0.02 inches to about 0.07 inches, including about 0.030 inches to about 0.060 inches and an outer diameter of about 0.05 inches to about 0.1 inches, including about 0.060 inches to 0.090 inches. The multi-head delivery system comprises a rotatable portion 140 connecting the plurality of tubes to the therapeutic agent insertion port 160 with an optional elbow joint. The material of the insertion port is generally of a more rigid plastic than that of the tubes and may be comprised of plastics such as polypropylene (PP), polyethylene (PE), polycarbonate (PC), and the like. The insertion port includes a connection means for releasably connecting a therapeutic agent delivery device (e.g., syringe) to the multi-head delivery system. In certain embodiments, the port includes locking means for engaging e.g., a locking syringe. The multi -head delivery system optionally further comprises a cap 170 for closing the multihead delivery system when not actively delivering a therapy to the individual. While various embodiments described herein show a three-head delivery system, those of ordinary skill in the art will recognize that other combinations of tubes are consistent with and fall within the scope of the general inventive concepts. Thus the number of tubes is not necessarily limited, so long as the multi-head delivery system can instill a plurality of wounds with a therapeutic agent to treat the individual’s tunneling wounds.

[00031] Figure 2 shows an embodiment wherein distal end portions 120 are cut to length to allow proper positioning of a tip portion 130 at each wound site. As can be seen from the figure, the top (120) and middle (120) show the tube that was cut to length, so the conical tip must be moved to position to look as seen in 130. Figure 3 shows an embodiment wherein each of three tubes are positioned at individual wound sites with tip portions 130 inserted into an opening and the tubes are secured with e.g., tape 301. A therapeutic agent delivery device 180 is releasably connected to the insertion port 160. The general inventive concepts contemplate positioning and securing the multi-head delivery system to the individual such that a first dose of therapeutic agent may be applied to the tunneling wounds in a clinical setting and the patient may then be able to deliver subsequent doses at home. In other embodiments, the multi-head delivery system is provided in the form of a kit, optionally including instructions for initial positioning and securing of the system and subsequent delivery of doses of therapeutic agent to the wounds at home, rather than in a clinical setting.

[00032] Figure 4 shows an embodiment wherein a therapeutic agent 402 has been instilled in a plurality of wound sites via the multi -head delivery system 100. Figure 5 shows an embodiment wherein a therapeutic agent has been delivered to the individual wound sites and the therapeutic agent delivery device (e.g., syringe) has been removed. The cap 170 is connected to cover the insertion port until further use is desired.

[00033] Figure 6 shows an alternative embodiment of a multi-head delivery system for simultaneously delivery of a therapeutic agent to a plurality of tunneling wound sites. The figure shows an exemplary multi-head delivery system 200 according to the general inventive concepts. The multi-head delivery system comprises a plurality of tubes 210, the tubes include a distal end 220 for insertion into a wound site and series of tip portion 230 along the length of the tubes. The multi-head delivery system comprises a rotatable portion 240 connecting the plurality of tubes to the therapeutic agent insertion port 260 with an optional elbow joint. The insertion port includes a connection means for releasably connecting a therapeutic agent delivery device (e.g., syringe) to the multi-head delivery system. In certain embodiments, the port includes locking means for e.g., a locking syringe. The multi-head delivery system optionally further comprises a cap 270 for closing the multi-head delivery system when not actively delivering a therapy to the individual.

[00034] Those of ordinary skill in the art will recognize that simultaneous treatment of wounds at substantial distance from one another is impractical (e.g., treatment of both arms of an individual or treatment of both chest and back wounds with a single therapy). However, the general inventive concepts can provide for substantially simultaneous delivery of a treatment to multiple wounds in proximity to one another, including multiple wounds within a 10 inch radius, including a radius of less than 6 inches, including a radius of less than 5 inches, and including a radius of from 2 to 6 inches.

[00035] Figure 7 shows an exemplary embodiment of a distal end portion of a tube 110 with a tip portion 130. In this embodiment, the tube further comprises a securement tab 180. In the embodiment shown in Figure 7, the securement tab is shown attached to the tip portion and is in the shape of a hollow rectangle wherein the securement tab is connected to the tip along one side of the securement tab. The securement tab allows an individual to anchor the multi-head deliver system at or near the wound site by positioning, for example, adhesive tape on the securement tab and securing to the individual’s skin. In this way, the tip portion is positioned and secured near the wound site to allow for subsequent (or repeated) instillation of a therapeutic agent without the need for (re)positioning of the device at the wound site. As can be seen from the figure, the distal end of the tip 131 is free from the securement tab to allow for positioning at an opening of a tunneling wound. While the securement tab is shown as a substantially hollow rectangular shape, those of ordinary skill in the art will recognize that a variety of shapes and sizes of securement tab are possible and will also fall within the scope of the general inventive concepts. Figure 8 shows an embodiment of the distal end portion of a tube in a similar fashion to that of Figure 7, including exemplary dimensions for elements of the securement tab.

[00036] Figure 9 is an image of an exemplary multi-head delivery system according to the general inventive concepts. The multi-head delivery system comprises a plurality of tubes, each with a tip portion, in fluid communication with a connection port, which is covered with a cap in the embodiment of Figure 8.

[00037] Figure 10 is an image showing components of a kit for treating a tunneling wound in conjunction with the multi-head delivery system according to the general inventive concepts. In certain embodiments, the kit includes at least one therapeutic agent (for example wound healing gels, creams or other topical agents, these can include agents both with and without antimicrobial activity; examples include, but are not limited to BlastX and Plurogel), a therapeutic agent delivery device (e.g., a locking syringe), syringe needles, sterilizing wipes, scissors, tweezers, a probe, gauze, tape, and bandages. Those of ordinary skill in the art will recognize that the individual elements of the kit may be customized to meet the needs of the individual and the setting (e.g., clinical versus at-home setting for therapy, instructions for treatment, etc.) and may not include one or more items in this embodiment but may still fall within the scope of the general inventive concepts.

[00038] While not wishing to be bound by any particular theory, it is now understood that TW conditions, including HS-associated TW, include biofilms in the wound, potentially contributing to the recurrence of the TW after front-line therapy, extending treatment and recovery times. Thus, the general inventive concepts contemplate delivery of therapeutic agents that can treat or prevent biofilm formation. Bacterial biofilms have shown resistance to common antibiotic therapy, whether oral or topical. Treatment of biofilms often requires multiple days of treatment at relatively high concentrations of, for example, anti-biotics. The general inventive concepts seek to provide systems and methods that allow an individual patient to deliver necessary treatment to multiple wound sites at home, over multiple days. This is expected to increase patient compliance and overall treatment effectiveness, while avoiding the invasive surgical de-roofing procedures in conventional methodologies.

[00039] Accordingly, various exemplary embodiments contemplate a method of simultaneously treating a plurality of tunneling wounds in an individual. The method comprises providing a therapeutic agent delivery device with a predetermined amount of a therapeutic agent contained therein and a multi-head delivery system, positioning tubes of the multi-head delivery system at individual tunneling wound sites, connecting the therapeutic agent delivery device with the multi-head delivery system in fluid communication, and engaging the therapeutic agent delivery device to simultaneously deliver/instill a therapeutic agent to each tunneling wound. In certain exemplary embodiments, the method further comprises cutting or otherwise customizing the length of one or more tubes of the multi-head delivery system to align with multiple tunneling wounds. In certain embodiments, the method further includes positioning a tip on a distal end of a tube, the tip may anchor the tube at the tunneling wound entry, allowing for better securement of the tube at the wound site. In certain embodiments, the method further includes securing the multi-head delivery system to the individual, including securing each tube at an individual wound entry. In certain embodiments, the method further includes disconnecting the therapeutic agent delivery device form the multi-head delivery system after the therapeutic agent has been administered (e.g., instilled). In certain embodiments, the method further includes closing an attached cap to an insertion port of the multi-head delivery system. In certain embodiments, the method contemplates repeated instillation of the therapeutic agent until an effective amount or length of treatment has been achieved, including daily, weekly, bi-weekly, or more. In certain embodiments, instillation may be required daily and the general inventive concepts contemplate administration using a first multi-head delivery device and later removal of the first device and positioning a second or further multi-head delivery device at the wound site to continue treatment.

[00040] In certain embodiments, the method also contemplates preparation of the tunneling wound site prior to positioning of the multi-head delivery system. Accordingly, in certain embodiments, the method further includes opening or incising a first end of a tunneling wound. Such an opening should be sufficient to introduce the tip portion of a tube of the multi-head delivery system. In certain embodiments, the method further includes opening or otherwise incising a second end of a tunneling wound.

[00041] The following examples illustrate features and/or advantages of the systems and methods according to the general inventive concepts. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the general inventive concepts, as many variations thereof are possible without departing from the spirit and scope of the general inventive concepts. In certain embodiments, a probe is inserted into the wound after opening. In certain embodiments, the opening or incision is less than 5 mm, including about 4 mm.

Example Treatment Procedure

[00042] Applicants devised a treatment known as the Lev-Tov Procedure hereafter (LTP) that is minimally invasive, minimally scarring, well tolerated, and simple to perform by a physician in an outpatient setting. The LTP involves identifying the TW by clinical exam or with an ultrasound device. Local anesthesia is administered. Then, a 4mm punch incision is made at the proximal end of the TW, or the existing TW opening is used for the initial incision. A simple probe is inserted through the length of the TW. The distal end of the TW is palpated and a second 4mm punch incision is created. Hemostasis is achieved with pressure. Then the treatment gel is instilled into the wound using a 3 cc syringe and the multi-head delivery system.

[00043] The LTP is an attempt to target biofilms which I hypothesize are the main reason for the chronicity and recurrence of TW in HS. The role of bacteria and biofilms in the pathogenesis of HS is becoming increasingly recognized, although their exact relationship to disease activity remains unclear. HS demonstrates many features that are consistent with a biofilm-driven disease, namely: chronic relapsing-remitting course with acute exacerbations, initial improvement with antibiotic therapy but quick relapse when the therapy is stopped, prolonged inflammation, localization to specific anatomical regions, and impaired wound healing.

[00044] Early data in a prospective study demonstrated that 93% of TWs resolved within an average of 12 days. A few patients noted mild, temporary stinging sensation when the treatment gel was applied. Otherwise, there were no adverse events. On the contrary, the quality of life of the patients improved in a meaningful way. The average DLQI score decreased from 13.3 (very large effect on patient life) at day 0 to 10.1 (moderate effect) on post op day 28, (p=0.006). The HisQOL score also decreased from 28.5 at VI to 22.9 at V3, p=0.002.

[00045] The delivery systems, and corresponding methods of the present disclosure can comprise, consist of, or consist essentially of the essential elements and limitations of the disclosure as described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise useful in cellular glass composition applications.

[00046] The systems of the present disclosure may also be substantially free of any optional or selected element or feature described herein, provided that the remaining composition still contains all of the required elements or features as described herein. In this context, and unless otherwise specified, the term “substantially free” means that the selected composition contains less than a functional amount of the optional ingredient, typically less than 0.1% by weight, and also including zero percent by weight of such optional or selected essential ingredient.

[00047] While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. It should be understood that only the exemplary embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.

Claims

Claims:

1. A multi-head delivery system for simultaneous delivery of a therapeutic agent to a plurality of wound sites, the system comprising: a plurality of tubes, the tubes include a distal end and a tip portion positioned on an exterior of the tube, a rotatable portion, and a therapeutic agent insertion port, wherein the rotatable portion connects the plurality of tubes to the therapeutic agent insertion port, and wherein the insertion port includes a connection means for releasably connecting a therapeutic agent delivery device to the multi-head delivery system.

2. The multi-head delivery system of claim 1 further comprising a cap for closing the insertion port when the insertion port is not engaged with a therapeutic agent delivery device.

3. The multi-head delivery system of claim 1, wherein the plurality of tubes comprises from 2-6 tubes.

4. The multi-head delivery system of claim 3, wherein the plurality of tubes comprises 3 tubes.

5. The multi-head delivery system of claim 3, wherein the tubes are between 2 and 10 inches in length.

6. The multi -head delivery system of claim 1, wherein the tip portion further comprises a securement tab and the tip is adapted to be repositioned between ends of the tube.

7. A method of simultaneously treating a plurality of tunneling wounds in an individual, the method comprising: providing a therapeutic agent delivery device with a predetermined amount of a therapeutic agent contained therein and a multi-head delivery system comprising a plurality of tubes, positioning a first tube of the multi-head delivery system at a first tunneling wound site, positioning a second tube of the multi-head delivery system at a second tunneling wound site, connecting the therapeutic agent delivery device and the multi-head delivery system to be in fluid communication with one another, and engaging the therapeutic agent delivery device to simultaneously deliver a therapeutic agent to the first tunneling wound and the second tunneling wound site.

8. The method of claim 7, further comprising altering the length of one or more tubes of the multi -head delivery system to align with multiple tunneling wounds prior to positioning the tube.

9. The method of claim 7, wherein each tube comprises a tip on a distal end of a tube and the method further comprises positioning the tip at an opening of the tunneling wound.

10. The method of claim 7, further comprising securing the multi -head delivery system to the individual, including securing the first tube at the first tunneling wound site and securing the second tube at the second tunneling wound site.

11. The method of claim 7 further comprising disconnecting the therapeutic agent delivery device form the multi-head delivery system after the therapeutic agent has been delivered.

12. The method of claim 11 further comprising engaging an attached a cap to an insertion port of the multi -head delivery system after disconnecting the therapeutic agent delivery device.

13. The method of claim 7 further comprising preparing a wound site by opening one end of the tunneling wound prior to positioning a tube at a tunneling wound site.

14. The method of claim 7, wherein the connecting and engaging steps are repeated for a predetermined course of treatment.

15. The method of claim 7, wherein positioning a tube of the multi-head delivery system comprises engaging the tip portion at the site of a tunneling wound to plug the wound and enable a regular forward flow of therapeutic treatment while avoiding retrograde flow.

16. A kit for treating a tunneling wound characterized by multiple adjacent tunneling wounds, the kit comprising: a multi-head delivery system for simultaneously delivery of a therapeutic agent to a plurality of wound sites, the system comprising: a plurality of tubes, the tubes include a distal end and a tip portion positioned on an exterior of the tube, a rotatable portion, and a therapeutic agent insertion port, wherein the rotatable portion connects the plurality of tubes to the therapeutic agent insertion port, and wherein the insertion port includes a connection means for releasably connecting a therapeutic agent delivery device to the multi-head delivery system; a therapeutic agent delivery device; and a predetermined amount of a therapeutic agent.

17. The kit according to claim 15 further comprising least one of syringe needles, sterilizing wipes, scissors, tweezers, a probe, gauze, tape, bandages, and instructions.

18. The kit of claim 15 wherein the plurality of tubes comprises from 2-6 tubes.

19. The kit of claim 15 wherein the plurality of tubes comprises 3 tubes.

20. The kit of claim 15 wherein the tubes are between 2 and 10 inches in length.

21. The kit of claim 15 wherein the tip portion is adapted to slide along a length of the tube.

22. The kit of claim 15, wherein the therapeutic agent is selected from wound healing gels, creams, and can include antimicrobial agents and therapeutic agents without antimicrobial activity.