Hemostasis delivery apparatus

Abstract

A hemostasis delivery apparatus includes a catheter assembly having a delivery catheter which extends along an axis A between proximal and distal delivery catheter ends to define a central lumen. A screw syringe assembly includes a barrel extending between proximal and distal barrel ends to define a barrel cavity which houses a base material. The screw syringe assembly includes a plunger which extends within the barrel and is axially advanceable along the axis to inject the base material into the central lumen of the delivery catheter. More specifically, the plunger is rotatable about the axis to establish the axial advancement of the plunger within the barrel via a threaded mechanical advantage. The hemostasis delivery apparatus can also include a pump assembly for subsequent use in axially advancing the base material from its pre-loaded condition within the central lumen and out the distal catheter end for deployment at a wound site.

Description

Atorney Docket # 113179-3HEMOSTASIS DELIVERY APPARATUS CROSS-REFERENCE TO RELATED APPLICATION

[0001] The subject application claims the benefit of and priority to U.S. Provisional Application Serial No. 63 / 776,313 filed on March 24, 2025, the entire contents of which are incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure relates to interventional devices such as those used in medical operations. More particularly, the present disclosure relates to an apparatus for use in delivering a therapeutic solution to a wound site for achieving hemostasis during or after an endoscopic medical procedure.BACKGROUND OF THE DISCLOSURE

[0003] Interventional devices are used for visualizing surfaces inside objects. For example, an endoscope is a medical instrument for visualizing the interior of a patient's body. Endoscopes can be used for a variety of different diagnostic and interventional procedures, including colonoscopy, bronchoscopy, thoracoscopy, laparoscopy, ureteroscopy and video endoscopy. Endoscopes typically have a control handle which is configured to allow a user to control a position of a distal tip of an endoscope tube during the procedure to investigate for the presence of any undesirable objects, such as the presence of stones, polyps or tumors during an endoscopic procedure, as an example.Atorney Docket # 113179-3

[0004] However, in various endoscopic procedures it is not uncommon to observe or cause bleeding of the surrounding tissues, which can create complications during the endoscopic procedures. Furthermore, when the bleeding occurs in the digestive tract, this gastrointestinal bleeding can pose significant patient risk. Thus, it is necessary to stop the localized bleeding for the safety of the patient.

[0005] In some cases, hemostasis can be achieved through mechanical means, such as clipping, electrocautery, etc. In other cases, hemostasis can be achieved through chemical means, such as by delivering and deploying reactive powders or fluids to the wound site which react to create a barrier (band aid) that retards bleeding. This localized delivery of chemical agents to the wound site is commonly achieved using catheters or similar introducer devices. For example, the catheter can be advanced within the patient to dispose a distal tip adjacent the wound site, after which the powders or fluids are injected into and through a lumen of the catheter.

[0006] In the case of powders, delivery through the lumen is via air pressure and results in random, non-exact “painting” of the wound site, as well as loss of endoscope visualization due to “snow effect”. Thus, it can be difficult to deliver the powder in a targeted manner to the wound site. In the case of fluids, an activator is often required to react with the initial base material to create the barrier layer. While initial delivery of the liquid base material can occur in a more targeted and accurate deployment to the wound site relative to powders, the liquid base material can migrate and run before the activator is applied due the effect of gravity on the base material, particularly when treating a vertically arranged wound site. Thus, even with successful initial deployment,Atorney Docket # 113179-3 prolonged adherence is poor and any resultant barrier does not last to achieve full hemostasis.

[0007] In an effort to improve (i.e., prevent) migration of the liquid base material after application to the wound site and before reaction with the activator, higher viscosity or gelatin base materials can be utilized, However, complications arise when deploying the higher viscosity or gelatin base materials through the lumen of the catheter. Put another way, current catheters or introducer devices encounter problems and / or have difficulty advancing the higher viscosity and gelatin base materials through the lumen and into deployment at the wound site.

[0008] Thus, there remains a continuing need for an improved apparatus and method of achieving hemostasis, particularly when utilizing higher viscosity or gelatin base materials.SUMMARY OF THE INVENTION

[0009] A hemostasis delivery apparatus for delivering a base material to a wound site of a patient includes a catheter assembly having a delivery catheter which extends along an axis from a proximal delivery catheter end to a distal delivery catheter end. The delivery catheter defines a central lumen extending between the proximal and distal delivery catheter ends. A screw syringe assembly includes a barrel extending from a proximal barrel end to a distal barrel end to define a barrel cavity which houses a predetermined amount of the base material. In operation, the screw syringe assembly is operably coupled to the catheter assembly to dispose the distal barrel end in fluid communication with the central lumen adjacent the distal delivery catheter end. TheAtorney Docket # 113179-3 screw syringe assembly includes a plunger which extends within the barrel and is axially advanceable along the axis and towards the distal barrel end to inject the predetermined amount of the base material into the central lumen of the delivery catheter. More specifically, the plunger is rotatable about the axis to establish the axial advancement of the plunger within the barrel via a threaded mechanical advantage. The theaded mechanical advantage for axially advancing the plunger provides an improved and metered means of injecting the base material into the central lumen, as compared to conventional means of manually pressing on a proximal plunger end of a plunger. This threaded mechanical advantage is also particularly beneficial to facilitate the advancement and use of base materials having higher viscosities or those being gelatinous, namely because the threaded mechanical advantage allows a user to successfully and more easily inject a viscous or gelatin base material into the central lumen by simply rotating the plunger, under significantly less strain and resistance.

[0010] In accordance with an aspect, the hemostasis delivery apparatus also includes a pump assembly that can be operably coupled with the catheter assembly for use in axially advancing the base material from its pre-loaded condition within the central lumen and out of the distal catheter end into deployment at the wound site. The pump assembly includes a pump handle and a piston catheter extending along the axis from a proximal piston catheter end connected to the pump handle to a distal piston catheter end disposed adjacent the proximal delivery catheter end in axial alignment with the delivery catheter. A piston component is disposed within the piston catheter and in a pre-loaded condition extends along the axis from a proximal piston component end disposed adjacent the proximal piston catheter end to a distal piston component endAtorney Docket # 113179-3 disposed adjacent the distal piston catheter end. A pump actuator is translatably disposed within the pump housing and is axially advanceable distally relative to the pump housing from a retracted position to an axially advanced position to axially drive the pre-loaded piston component along the axis and distally within and relative to the piston catheter for axially advancing the distal piston component end into the central lumen to advance the pre-loaded base material through the central lumen and out of the distal catheter end to deliver the base material to the wound site. As will be described in more detail below, the use of the axially advanced piston component to drive the base material through the central lumen provides a more effective and efficient hemostasis delivery apparatus, particularly when a viscous or gelatin base material is utilized. Put another way, use of the pump assembly improves on and addresses deficiencies found in the prior art delivery apparatus, particularly when trying to advance a viscous or gelatin base material through a central lumen and into deployment at the wound site, namely because the pump assembly utilizes a piston component to advance and deploy the base material.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Other aspects of the present disclosure will be readily appreciated, as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein:

[0012] Figure 1 is a perspective view of a hemostasis delivery apparatus including a catheter assembly, a screw syringe assembly and a pump assembly;

[0013] Figure 2 is a fragmentary, perspective view of a “co-axial” delivery catheter of the catheter assembly illustrating an outer sheath concentrically disposedAtorney Docket # 113179-3 around a delivery catheter and its central lumen to define an annulus extending between an inner surface of the outer sheath and an outer surface of the delivery catheter;

[0014] Figure 3 is a cross-sectional, side view of the catheter assembly illustrating a delivery hub arranged on the delivery catheter and including an outer sheath hub translatably disposed within a hub chamber and disposed adjacent an activator port to initially define a sealed chamber for the catheter assembly;

[0015] Figure 4 is a perspective view of the screw syringe assembly illustrating a barrel initially filled with a predetermined amount of base material and a plunger including a rotation knob and a series or plurality of plunger threads;

[0016] Figure 5 is a side view of the screw syringe assembly of Figure 4 operably connected or coupled to the delivery hub of the catheter assembly;

[0017] Figure 6 is a side view of the screw syringe assembly illustrating the plunger being rotated relative to a housing to effectuate axial advancement and translation of the plunger within the barrel via a threaded mechanical advantage to advance the base material into the central lumen of the delivery catheter;

[0018] Figure 7 is a cross-sectional side view of the screw syringe assembly illustrating a split nut disposed within a housing and biased into engagement with the plunger to threadingly couple a plurality of split nut threads with the series of plunger threads and establish the threaded mechanical advantage;

[0019] Figure 8 is a cross-sectional side view of the screw syringe assembly illustrating a quick draw button begin radially depressed by a user to release the threaded mechanical advantage and engagement of the split nut threads from the plunger threadsAtorney Docket # 113179-3 for allowing the user to quickly and proximally draw back the plunger from within the barrel cavity;

[0020] Figure 9 is a perspective view of the split nut;

[0021] Figure 10 is a side view of the pump assembly illustrating a pump handle in cross-section to more clearly show a central pump chamber disposed between an actuator portion and a handle portion, a pump actuator translatably disposed within the actuator portion, a pump reservoir disposed within the handle portion, and a piston catheter releasably connected to an exit port of the handle portion and extending to a female luer connector;

[0022] Figure 11 is a side-view of a piston component disposed within the piston catheter;

[0023] Figure 12 is a fragmentary side view of the piston component illustrating an inner core disposed and extending within an outer polymer jacket;

[0024] Figure 13 is a side view of the catheter assembly and the pump assembly illustrating the female luer connector of the piston catheter releasably connected to the delivery hub and an activator syringe secured in a holster of the pump handle and disposed in fluid communication with the activator port of the delivery hub via an activator line;

[0025] Figure 14A is a side view of the pump assembly illustrating the pump actuator disposed in a static pump position;

[0026] Figure 14B is a side view of the pump assembly illustrating the pump actuator being retracted from the static pump position to a retracted pump position to drawAtorney Docket # 113179-3 a predetermined amount of liquid (e.g., sterile water) from the pump reservoir and into the pump chamber and an actuator chamber;

[0027] Figure 14C is a side view of the pump assembly with the catheter assembly and related delivery hub removed to illustrate the pump actuator being advanced distally from its retracted position and towards the exit port to an axially advanced position to axially advance the liquid from the pump chamber and into the piston catheter to exert a hydraulic pressure on the piston component and axially advance the piston component within the piston catheter and out of the distal piston catheter end;

[0028] Figure 14D is a magnified view of a portion of Figure 14C to more clearly illustrate the liquid being advanced into the piston catheter to exert the hydraulic pressure on a proximal piston component end of the piston component;

[0029] Figure 14E is a side view of the pump assembly with the catheter assembly and related delivery hub shown in a re-coupled relationship with the pump assembly to illustrate that, when the pump actuator is advanced distally from the retracted position to the axially advanced position (as shown in Figure 14C), a distal piston component end of the piston component is axially advanced into the central lumen of the delivery catheter to advance the pre-loaded base material through the central lumen and out of the distal catheter end;

[0030] Figure 15A is a perspective view of a first arrangement of a “dynam ic” co-axial delivery catheter;

[0031] Figure 15B is a cross-sectional view of the first arrangement of the “dynamic” co-axial delivery catheter illustrating the outer sheath disposed in overlayingAtorney Docket # 113179-3 relationship with an annular flange adjacent a distal catheter end to initially seal the annulus from an environment of the delivery catheter;

[0032] Figure 16 is a cross-sectional and fragmentary side view of the catheter assembly and pump assembly illustrating an activator being advanced within the activator line and towards and into the sealed chamber of the delivery hub in response to the user initially engaging the activator syringe;

[0033] Figure 17 is a cross-sectional side view of the catheter assembly sequentially illustrating the activator building up pressure within the sealed chamber to effectuate translation of the outer sheath hub and the outer sheath connected thereto proximally relative to the delivery catheter and its central lumen for allowing the activator to pass through the annulus and travel towards the distal catheter end;

[0034] Figure 18 is a perspective view of the first arrangement of the “dynamic” co-axial delivery catheter illustrating the outer sheath being translated and slid in response to the activator being delivered to the sealed chamber (as shown in Figure 17) to dispose the distal outer sheath end in proximally spaced relationship with the annular flange such that the outer sheath no longer covers the annular flange and the annulus is open adjacent the distal catheter end for allowing the activator to pass therethrough;

[0035] Figure 19A is a perspective view of a second arrangement of the “dynamic” co-axial delivery catheter;

[0036] Figure 19B is a perspective view of the second arrangement of the “dynamic” co-axial delivery catheter after the outer sheath has translated proximally relative to the delivery catheter and its central lumen in response to the activator beingAtorney Docket # 113179-3 delivered to the sealed chamber (as shown in Figure 17) to illustrate the annular flange defining a plurality of axially extending flow channels which commence in axially spaced relationship with the distal catheter end but extend proximally through a remaining portion of the annular flange and into fluid communication with the annulus for establishing indirect fluid communication of the annulus with the environment of the delivery catheter when the outer sheath is slid relative to the annular flange until a portion of the axially extending flow channels are no longer covered by the distal outer sheath end to establish the open condition of the annulus;

[0037] Figure 19C is a perspective view of the second arrangement of the “dynamic” co-axial delivery catheter transparently illustrating the outer sheath to more clearly show the axially extending flow channels extending through the annular flange;

[0038] Figure 20A is a perspective view of an alternative “static” co-axial delivery catheter including an elastomeric cap disposed in overlaying and sealed relationship with a distal outer sheath end of the outer sheath to initially seal the distal portion of the annulus from an environment of the delivery catheter;

[0039] Figure 20B is a perspective view of the alternative “static” co-axial delivery catheter after the activator has passed to the distal outer sheath end to overcome a cracking pressure of the elastomeric cap and open the annulus adjacent the distal catheter end for allowing the activator to pass therethrough; and

[0040] Figure 20C is a cross-sectional view of the alternative “static” co-axial delivery catheter to more clearly illustrate the overlaying and sealed relationship of the elastomeric cap with an outer surface of the delivery catheter.Atorney Docket # 113179-3 DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0041] Example embodiments will now be described more fully with reference to the accompanying drawings. In general, the subject embodiments are directed to a hemostasis delivery apparatus for achieving hemostasis during or after an endoscopic medical procedure. However, the example embodiments are only provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, and that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. For example, while the hemostasis delivery apparatus and its related components are described for use in advancing base materials and activators to a wound site, the delivery apparatus could also be used and implemented for use when hemostasis is not required (i.e., used in other medical applications where a base material and / or activator is required to be advanced to a vessel of a patient, for other purposes). In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0042] Referring to the Figures, wherein like numerals indicate corresponding parts throughout the several views, a hemostasis delivery apparatus 10 is generally shown and according to the preferred embodiment, will ultimately be described in relation to the use of a coaxial delivery catheter 14 for the delivery of a viscous or gelatin liquid base material 22 followed by an activator 127 to a wound site within a patientAtorney Docket # 113179-3 (e.g., within a vessel of the patient) for achieving hemostasis. However, the exemplary description is not limiting, and the teachings herein, especially with regard to the pump assembly 80, may be applied to other methods of achieving hemostasis, such as via delivery of just the viscous / gelatin base material 22 via a single lumen delivery catheter of the hemostasis delivery apparatus 10 without departing from the scope of the disclosure and invention. Put another way, delivery of the activator (if required) can be achieved with or without the hemostasis delivery apparatus 10 disclosed and illustrated herein. Furthermore, the screw syringe assembly 40, the pump assembly 80 and / or the co-axial “dynamic” and “static” delivery catheters can be used separately from one another, for purposes other than achieving hemostasis, without departing from the scope of the subject disclosure. Their disclosed use collectively as part of a delivery apparatus for achieving hemostasis is an enabling and exemplary disclosure. Other modifications and variations of the present disclosure are also possible in light of the following teachings and may be practiced otherwise than as specifically described.

[0043] As illustrated in Figures 1-3 and 16-17, the hemostasis delivery apparatus 10 includes a catheter assembly 12 having a delivery catheter 14 which extends along a main axis A from a proximal delivery catheter end 16 to a distal delivery catheter end 18 for being located inside a patient’s body and adjacent a wound site. As best shown in Figure 2, the delivery catheter 14 defines and has a central lumen 20 extending between the proximal and distal delivery catheter ends 16, 18, which as will be described in more detail below receives and is pre-loaded with a predetermined amount (e.g., 5 ml) of base material 22, either prior to or after the delivery catheter 14 is located inside of the patient’s body, for use in achieving hemostasis at the wound site. The baseAtorney Docket # 113179-3 material 22 is preferably comprised of a high-viscosity liquid or gelatin-based material having a viscosity such that deployment through an anatomically compatible catheter lumen is ergonomically difficult or improbable and thus the base material 22 is viscous enough to maintain its relative position on the anatomy during and after deployment with the patient’s body with minimal migration. For example, in a preferred embodiment, the base material 22 is comprised of sodium alginate. However, other viscous base materials 22 could be utilized without departing from the scope of the subject disclosure.

[0044] As best illustrated in Figure 3 and 16-17, the catheter assembly 12 includes a delivery hub 24 arranged on the delivery catheter 14 adjacent the proximal delivery catheter end 16. The delivery hub 24 includes a hub body 26 which extends along the main axis A from a distal hub end 28 to a proximal hub end 30 disposed proximal of and in spaced relationship with the proximal delivery catheter end 16. The hub body 26 defines a hub chamber 32 disposed between the proximal and distal hub ends 28, 30, and a threaded bore 34 having mating features 36, such as internal threads 36, is disposed adjacent the proximal hub end 30. As best illustrated in Figures 3 and 16-17, the threaded bore 34 is disposed in communication with the hub chamber 32 and is open to an environment of the catheter assembly 12. Thus, as further illustrated in Figures 3 and 16-17, the central lumen 20 of the delivery catheter 14 extends through the hub chamber 32 and into the threaded bore 34 such that the proximal delivery catheter end 16 terminates within the threaded bore 34 in spaced relationship with the proximal hub end 30.

[0045] As best illustrated in Figures 4-8, in a preferred arrangement, a screw syringe assembly 40 having a barrel 42 initially filled with the predetermined amount ofAtorney Docket # 113179-3 base material 22 is releasably threaded to the threaded bore 34 of the hub body 26 for injecting the base material 22 into the central lumen 20 and establishing the pre-loaded condition of the catheter assembly 14. However, other aspects of introducing the base material 22 into the central lumen 20 of the delivery catheter 14 to pre-load the catheter assembly 14 could be utilized, without departing from the scope of the subject disclosure, namely if the delivery apparatus 10 is used without the screw syringe assembly 40. The barrel 42 extends from a proximal barrel end 44 to a distal barrel end 46 to define a barrel cavity 48 for housing the predetermined amount of base material 22. The distal barrel end 46 includes a luer lock fitting 50 having features, e.g., external threads 52, being complementary to the mating features 36 of the hub body 26 to establish the connected relationship between the catheter assembly 12 and the syringe assembly 40. The distal barrel end 46 also includes a tip 54 disposed in fluid communication with the barrel cavity 46 and which is inserted into central lumen 20 at the proximal delivery catheter end 16 when the distal barrel end 46 of the barrel 42 is releasably coupled and threaded to the proximal hub end 28 of the hub body 26. (See e.g., Figure 5).

[0046] The screw syringe assembly 40 includes a plunger 56 which extends within and is translatably disposed within the barrel 42 and axially advanceable along the main axis A and towards the distal barrel end 46 to inject the predetermined amount of base material 22 into the central lumen 20 of the delivery catheter 20. However, in lieu of the conventional means for syringes in which the plunger 56 is manually pushed towards the distal barrel end 46, such as with a thumb of the user, in a preferred arrangement the plunger 56 is rotated about the main axis A to effectuate the axialAtorney Docket # 113179-3 advancement and translation of the plunger 56 within the barrel 42 via a threaded mechanical advantage. (See, e.g., Figures 5-8).

[0047] More specifically, as best illustrated in Figures 7-8, the screw syringe assembly 40 includes a housing 58 disposed at the proximal barrel end 44 and which defines a through-passage 60 extending along the main axis A and which is disposed in communication with the barrel cavity 48. Thus, the plunger 56 extends from a proximal plunger end 62 disposed outside of the housing 58 and into and along the through-passage 60 to terminate at a distal plunger end 64 disposed inside of the barrel cavity 48.The plunger 56 includes a series or plurality of plunger threads 66 extending between the proximal and distal plunger ends 62, 64 and a plunger seal 67 is disposed on the distal plunger end 64 for establishing sealed relationship with the barrel cavity 48. A split nut 68 presenting a plurality of split nut threads 70 is also disposed within the housing 58 and is biased radially towards the through-passage 60 and into engagement with the plunger 56 by a biasing member 72 (e.g. , spring or the like) to threadingly couple the split nut threads 66 and the plunger threads 70 and establish the threaded mechanical advantage. (See Figure 7). As best illustrated in Figure 9, the split nut 68 is generally u-shaped such that the plurality of split nut threads 70 have a hemispherical cross-section when viewed transverse to the main axis A, which allows them to be advanced into threaded engagement with the plunger threads 66. However, other means of establishing a threaded engagement between the housing 58 and the plunger 56 (i.e. , without a split nut 68) to establish the threaded mechanical advantage could be utilized without departing from the scope of the subject disclosure.Atorney Docket # 113179-3

[0048] A rotation knob 74 is attached to the proximal plunger end 62 and is rotatable by a user to drive the plunger 56 towards the distal barrel end 46 with the threaded mechanical advantage established between the threadingly connected relationship of the plunger and split nut threads 66, 70, which provides an improved and metered means of injecting the viscous base material 22 into the central lumen 20 of the delivery catheter 14 over conventional means of manually pressing on the proximal plunger end 62. This threaded mechanical advantage is also beneficial to facilitate the use of higher viscosity base materials 22, namely because this threaded mechanical advantage allows the user to successfully and more easily inject the viscous base material 22 into the central lumen 20 by simply rotating the rotation knob 74, under significantly less strain and resistance. As best illustrated in sequential Figures 7-8, the housing 58 includes a quick draw button 76 which can be pressed downwardly by the user and radially into engagement with the split nut 68 to overcome the bias of the biasing member 72 and release the threaded mechanical advantage and engagement of the split nut threads 72 from the plunger threads 66. This allows the user to quickly draw the plunger 56 axially backwards, in a direction backwards towards the proximal plunger end 56, such as when initially loading the base material 22 into the barrel cavity 48 by being drawn into the syringe assembly 40 and / or when injection of the base material 22 is complete. Once the viscous or gelatin base material 22 is introduced into the central lumen 20 of the delivery catheter 14 to establish the pre-loaded condition, the syringe assembly 40 can be threadingly decoupled from the catheter assembly 12.

[0049] As illustrated in Figures 1 and 10-14D, the hemostasis delivery assembly 10 includes a pump assembly 80 operably coupled with the catheter assemblyAtorney Docket # 113179-3 12 for axially advancing the viscous or gelatin base material 22 from its pre-loaded condition within the central lumen 22 of the delivery catheter 14 and out of the distal catheter end 18 into deployment at the wound site. The pump assembly 80 includes a pump handle 82 having an actuator portion 84 extending along the main axis A (defined relative to when the pump assembly 80 is operably connected to the catheter assembly 12, as will be described in more detail below) and a handle portion 86 which extends downwardly and radially away from (and preferably transverse to) the actuator portion 84. The pump handle 82 defines a central pump chamber 88 aligned on the main axis A and disposed at an intersection of the actuator and handle portions 84, 86. A pump actuator 90 extends within the actuator portion 84 from a distal actuator end 91 disposed adjacent the pump chamber 88 (in the static pump position, as shown in Figures 10 and 14A) to a proximal actuator end 92 disposed outside of and proximally to the actuator portion 84 of the pump handle 82. As best illustrated in Figure 14B-D, the pump actuator 90 is translatably disposed within the actuator portion 84 and can be retracted proximally along the main axis A from its static pump position (Figure 14A) to a retracted pump position (Figure 14B) which establishes an actuator chamber 93 disposed in the actuator portion 84 and in a space vacated by the retracted pump actuator 90. As best illustrated in Figures 10,14B-C and 14E, the actuator chamber 93 is disposed in fluid communication with the pump chamber 88 but separated therefrom by a two-way fluid valve 94.

[0050] As further illustrated in Figures 10, 14B-C and 14E, the handle portion 86 of the pump assembly 80 houses a pump reservoir 96 disposed in fluid communication with the pump chamber 88 but separated therefrom by a first one-way fluid valve 98 that is configured to allow fluid flow from the pump reservoir 96 to the pump chamber 88 butAtorney Docket # 113179-3 prevent the reverse flow of fluid back there through. In a preferred arrangement, the pump reservoir 96 is filled with a predetermined amount (e.g., 5 ml) of liquid 100 (e.g., sterile water) being equal to the predetermined amount (e.g., 5 ml) of base material 22 loaded in the central lumen 20 of the delivery catheter 14. (See Figure 10). However, other equivalents of liquid 100 and base material 22 could be utilized without departing from the scope of the subject disclosure. As the pump actuator 90 is retracted from the static pump position (Figure 14A) to the retracted pump position (Figure 14B), the predetermined amount of liquid 100 is drawn from the pump reservoir 96 and through the first one-way fluid valve 98 into the pump chamber 88 and the actuator chamber 93. As further illustrated in Figure 10, the pump handle 82 defines an exit port 102 aligned on the main axis A, and which is arranged distally adjacent and in fluid communication with the pump chamber 88. The exit port 102 houses a second one-way fluid valve 104 configured to allow fluid flow distally out of the exit port 102 from the pump chamber 88 but prevents the reverse proximal flow of fluid flow back through the exit port 102.

[0051] As further illustrated in Figures 10 and 14A-D, the pump assembly 80 includes a piston catheter 106 extending along the main axis A (when the pump assembly 80 is operably coupled to the catheter assembly 12) from a proximal piston catheter end 108 that is releasably connected to the exit port 102 of the pump handle 82 and disposed in fluid communication with the pump chamber 88 to a distal piston catheter end 110 that presents a female luer connector 112, that as described in more detail below is operably coupled with the threaded bore 34 of the hub body 26 to establish the operable coupling between the pump assembly 80 and the catheter assembly 12. (See e.g., Figure 14B). In this operably coupled relationship, the distal piston catheter end 110 is alsoAtorney Docket # 113179-3 disposed adjacent the proximal catheter end 16 and axially aligned with the central lumen 20. As illustrated in Figures 11 and 14B-D, a piston component 114 is disposed within the piston catheter 106, and in its pre-loaded condition extends along the main axis A (again defined relative to the pump assembly 80 being operably connected to the catheter assembly 12, as will be described in more detail below) from a proximal piston component end 116 disposed adjacent the proximal piston catheter end 108 to a distal piston component end 118 disposed adjacent the distal piston catheter end 110. As further illustrated in Figure 12, the piston component 114 preferably includes an inner core 120 that extends between the distal and proximal piston component ends 116, 118 and is housed within an outer polymer jacket 122. The inner core 120 is preferably comprised of nitinol to provide for column strength, flexibility and kink resistance during axial movement of the piston component 114 within the piston catheter 106 in response to translation or advancement of the pump actuator 90 proximally from its retracted position and towards an axially advanced position, as shown in Figures 14C and 14E, as will be described in more detail immediately below. The flexibility of the inner core 120 is particularly advantageous when the viscous base material 22 is advanced through the central lumen 20 (as will be described in more detail below), namely because a large force is required to push this more viscous fluid and the flexibility ensures that the piston component 114 does not incur a permanent bend or kink.

[0052] As best illustrated in Figures 14B and 16, after the delivery catheter 14 of the catheter assembly 12 is pre-loaded with the base material 22, the female luer connector 112 on the piston catheter 106 is threadingly engaged with the internal threads 36 extending in the threaded bore 34 of the delivery hub 24 to releaseably interconnectAtorney Docket # 113179-3 the catheter assembly 12 and the pump assembly 80 to one another in aligned relationship along the main axis A. This releasably interconnected relationship also disposes the piston catheter 106 in axially aligned relationship with the delivery catheter 14 along the main axis A, such that a seal is created by the female luer connector 112 on the pump assembly 80. More specifically, since this is a luer taper lock, the threads on the swivel enables a screw mechanism which axially compresses and holds the luer mating features. This creates the sealed central lumen 20 preventing leaking at this joint. Thus, with reference to Figures 14C-E, as the pump actuator 90 is advanced distally by the user from its retracted position and axially towards the exit port 102 to the axially axially advanced position (See Figured 14C and 14E), the pump actuator 90 pushes the predetermined amount of liquid (e.g., sterile water) 100 previously drawn into the central pump chamber 88 and the actuator chamber 92 out of the exit port 102 and into the piston catheter 106. (See Figure 14E). The axially advanced liquid 100 then engages and exerts a hydraulic pressure on the proximal piston component end 118 to axially drive the piston component 114 along the main axis A and distally within and relative to the piston catheter 106 to advance and dispose the distal piston component end 118 into the central lumen 20 of the delivery catheter 14. As the piston component 114 continues to travel within the piston and delivery catheters 106, 14 in response to continued translation of the pump actuator 90, the distal piston component end 118 of the piston component 114 pushes and advances the base material 22 through the central lumen 20 and out of the distal catheter end 18 to effectuate delivery of the base material 22 to the wound site. (See Figure 14E). Axial advancement of the piston component 114 by the pump actuator 90 ceases when the pump actuator 90 is axially advanced to the axially advanced positionAtorney Docket # 113179-3 (and which can be the same as the static position), and no additional amount of the liquid 100 can exit the pump handle 82 through the exit port 102. Thus, the pump assembly 80, and particularly use of the predetermined amount of sterile water 100, advantageously provides for and translates a metered, accurate dose of the viscous base material 22 out the distal catheter end 18 and into deployment at the wound site. Put another way, the predetermined amount of sterile water 100 advantageously controls axial advancement of the piston component 114, namely because once the pump actuator 90 is advanced to the axially advanced position (and back in the static condition), no additional liquid 100 can be advanced out of pump and actuator chambers 90, 92 and directed out of the exit port 102 by the pump actuator 90. Thus, no further hydraulic pressure remains to advance the piston component 114 farther along the main axis A. Additionally, use of the axially advanced piston component 114 to drive the base material 22 through the central lumen 20 provides a more effective and efficient hemostasis delivery apparatus 10, particularly when a viscous or gelatin base material 22 is utilized. Put another way, use of the pump assembly 80 improves on and addresses the deficiencies found in the prior art delivery apparatus when trying to advance a viscous base material through a central lumen and into deployment at the wound site, namely because the pump assembly 80 utilizes a hydraulic means to advance and deploy the base material.

[0053] As best illustrated in Figures 11-12, the piston component 114 includes a plurality of proximal seals 124 disposed on the proximal piston component end 116 and which extend radially outwardly into sealed relationship with an inner surface of the piston catheter 106. Accordingly, the proximal seals 124 maintain the pressurized liquid proximal of the proximal piston component end 116 during advancement of theAtorney Docket # 113179-3 pump actuator 90 from the retracted position and axially towards the exit port 102 and the piston catheter 106. (See Figures 14C and 14E). Thus, the proximal seals 124 assist in building up the hydraulic pressure within the piston component 106 as applied to the proximal piston component end 116 by the liquid 100 when advanced into the piston catheter 106. As further illustrated in Figure 12, the piston component 114 includes a plurality of distal wiper seals 126 disposed on the distal piston component end 118 and which extend into sealed and abutting relationship with the inner surface of the piston catheter 106 when the piston component 114 is disposed in its pre-loaded and unadvanced condition. As the piston component 114 is axially advanced by the pump actuator 90 to dispose the distal piston component end 118 within the central lumen 20 of the delivery catheter 14, the distal wiper seals 126 then transition into sealed and abutting relationship with the inner surface of the central lumen 20 of the delivery catheter 14. As a result, the distal wiper seals 126 act as a wiper during axial movement of the piston component 114 within the delivery catheter 14, making sure that all of the base material 22 is advanced towards the distal catheter end 18. The proximal seals 124 and distal wiper seals 126 also maintain separation of and prevent the liquid 100 from reaching and mixing with the base material 22. Additionally, the plurality of seals 124, 126 accommodate maintenance of sealing both distal and proximal ends as the piston moves through and beyond the connected luer joint at the delivery catheter hub 24.

[0054] Furthermore, although Figure 11 illustrates the piston component 114 having a length of approximately fourteen inches, the length of the piston component 114 is variable, preferably being defined by the parameters of the central lumen 20 and volume of viscous base material 22 to be delivered. More specifically, an ID of the centralAtorney Docket # 113179-3 lumen 20 and volume of base material 22 result in a fluid column of X length. The delivery catheter 14 has a minimum length specification to be compatible with particular endoscopes, plus a length extended beyond the distal end of the endoscope to reach the therapy site, plus the length extending out of the proximal end of the endoscope to be accessible / ergonomic to the user. Assuming that the viscous fluid column is deposited to reside within the central lumen and ending near the distal end of the catheter for deployment, the space between the proximal end of the fluid column and the pump assembly 80 is the length the piston accommodates. In summary, length of fluid column - length of catheter shaft = length of piston component 114.

[0055] After the base material 22 has been deployed at the wound site, an activator 127 is often then introduced and applied to the wound site to effectuate a chemical reaction for solidifying the base material 22 and creating a mechanical and chemical bond between the base material 22 and the mucosa to maintain the base material’s 22 position and facilitate hemostasis of the wound site reliably over a prolonged period of time. As noted in the leading Paragraphs of this Detailed Description section, this activator 127 could be applied by an introducer device separate from the hemostasis delivery apparatus 10 without departing from the scope of the disclosure and the inventive principles of the catheter assembly 12 and pump assembly 80. However, in a preferred arrangement of the subject disclosure, the activator 127 is also deployed to the wound site via the hemostasis delivery apparatus 10.

[0056] More specifically, as best illustrated in Figure 2, in this additional arrangement of the hemostasis delivery apparatus 10, the catheter assembly 12 includes an outer sheath 128 which is concentrically arranged around the delivery catheter 14 toAtorney Docket # 113179-3 define an annulus 130 extending radially there between (i.e. , between an inner surface of the outer sheath 128 and an outer surface of the delivery catheter 14), and establish a “co-axial” delivery catheter arrangement. As best illustrated in Figures 15A-17, the outer sheath 128 extends along the main axis A from a distal outer sheath end 132 disposed adjacent the distal catheter end 18 to a proximal outer sheath end 134 that terminates within the hub chamber 32 of the hub body 26 and in distally spaced relationship with the proximal catheter end 16 of the delivery catheter 14, namely because, as noted previously, the delivery catheter 14 and its central lumen 20 extend farther and past the proximal outer sheath end 134 to more proximally terminate within the threaded bore 34. A sealed relationship is established between the outer sheath 128 and the hub body 26 adjacent the distal hub end 28 to isolate the annulus 130 from an environment of the hub body 26. The activator 127 is introduced into the annulus 130 adjacent the proximal outer sheath end 134 and passes within the annulus 130 (i.e., between the outer sheath 128 and the delivery catheter 14) until reaching the distal outer sheath end 132 and being deployed at the wound site for reaction with the base material 22.

[0057] As best illustrated in Figures 10, 13-14C and 14E, in a preferred arrangement, the actuator portion 84 includes a holster 136 secured to and extending upwardly from the actuator portion 84, and an activator source, such as an activator syringe 138, is pre-filled with the activator 127 and positioned within the holster 136 for easy and ergonomic access by the user. As best illustrated in Figures 3 and 16-17, the hub body 26 of the delivery hub 24 defines an activator port 139 disposed in fluid communication with the hub chamber 32, and an activator line 140 extends from a proximal line end 142 connected to the activator syringe 138 to a distal line end 144Atorney Docket # 113179-3 connected to the activator port 139 for delivering the activator 127 from the activator syringe 138, into the hub chamber 32 and ultimately to the annulus 130, such as via a user pressing on a thumb rest 146 of the activator syringe 138 to advance the activator 127 through the activator line 140. The pressure created by the user manually pressing the thumb rest 146 of the activator syringe 138 is ultimately sufficient to advance the activator 127 through the annulus 130 and to the distal outer sheath end 132. However, other means of introducing the activator 127 to the annulus 130, without use of a syringe, can be utilized without departing from the subject disclosure. As will be appreciated in view of the following more detailed disclosure, use of the “co-axial” delivery catheter 14 in any embodiment provides a means of delivering the base material 22 and the activator 127 through separate lumens (namely the central lumen 20 for the base material 22 and the annulus 130 for the activator 127) so as to prevent premature mixing of these materials before reaching the wound site.

[0058] In a first embodiment of the “co-axial” delivery catheter 14, the outer sheath 128 remains in a static position as the activator 127 is advanced within the annulus 130 towards the distal outer sheath end 144. (See Figures 20A-20C). In this first “static” embodiment, the proximal outer sheath end 134 of the outer sheath 128 (and thus a proximal portion of the annulus 130) is disposed in fluid communication with the hub chamber 32. As correspondingly shown in Figure 20A, an elastomeric cap 148 is disposed in overlaying and sealed relationship with the distal outer sheath end 132 of the outer sheath 128 to initially seal the distal portion of the annulus 130 from an environment of the delivery catheter 14, namely during deployment of the base material 22 out of the distal catheter end 18 of the central lumen 20. Thus, the elastomeric cap 148 initiallyAtorney Docket # 113179-3 prevents the base material 22 (and other contaminants present at the wound site) from migrating into the annulus 130 and clogging up the ensuing delivery channel for the activator 127.

[0059] As mentioned above, after the base material 22 is deployed at the wound site, the activator 127 is delivered from the activator syringe 138, through the activator port 139, into the hub chamber 32 and sequentially to the annulus 130. As best shown in Figure 20B, as the activator 127 is advanced through the annulus 130 and to the distal outer sheath end 132, the activator 127 presents adequate force to overcome the cracking pressure of the elastomeric cap 148 to allow the activator 127 to be deployed at the wound site. Put another way, the elastomeric cap 148 overlays the distal outer sheath end 132 and extends to and remains in a sealed relationship with the outer surface of the delivery catheter 14 during most of the medical procedure, until the activator 127 is advanced through annulus 130 and to the distal outer sheath end 132 to then free the sealed relationship of the elastomeric cap 148 with the outer surface of the delivery catheter 14. As shown in Figure 20B, the annulus 130 is now open adjacent the distal outer sheath end 132 for delivery of the activator 127 to the wound site.

[0060] In a second embodiment of the “co-axial” delivery catheter 14, the outer sheath 128 is “dynamic” - i.e., driven to axially translate or slide relative to the underlying delivery catheter 14 and its central lumen 20 to open the annulus 130 and allow the activator 127 to be advanced towards the distal outer sheath end 132. (See Figures 16-19C). As best shown in Figures 15A-15B and 19A, in this second “dynamic” embodiment, the delivery catheter 14 defines an annular flange 150 disposed adjacent the distal catheter end 18 and which is stepped up (i.e., has a larger flange outer diameter)Atorney Docket # 113179-3 relative to the outer surface of the remaining delivery catheter 14 extending from the annular flange 150 to the proximal catheter end 16. The distal outer sheath end 132 of the outer sheath 128 has an inner outer sheath diameter being approximately equal to the stepped-up, larger flange outer diameter of the annular flange 150 and thus is initially disposed in overlaying and sealed relationship with the annular flange 150 to initially seal the distal portion of the annulus 130 from an environment of the delivery catheter 14, namely during deployment of the base material 22 out of the distal catheter end 18 of the central lumen 20. Thus, similar to the elastomeric cap 148 in the “static” arrangement, the line-fit and sealed relationship between the outer sheath 128 and the annular flange 150 adjacent the distal outer sheath end 132 initially prevents the base material 22 (and other contaminants present at the wound site) from migrating into the annulus 130 and clogging up the ensuing delivery channel for the activator 127.

[0061] As best shown in Figures 3 and 16-17, an outer sheath hub 152 is slideably or retractably disposed within the hub chamber 32 from a proximal sheath hub end 154 disposed proximal of and adjacent the activator port 139 to a distal sheath hub end 156 connected to the proximal outer sheath end 134 of the outer sheath 128. As further shown in Figures 15-16, the outer sheath hub 152 is also disposed in concentrically surrounding and axially translatable relationship with the delivery catheter 14 and the central lumen 20 between the proximal and distal sheath hub ends 154, 156 to define a hub passageway 157 which is disposed in fluid communication with the annulus 130 that extends distally of the outer sheath hub 152. A distal o-ring 158 is disposed within the hub chamber 32 distally adjacent the activator port 139, extending radially between an inner surface of the hub chamber 32 and the outer sheath hub 152,Atorney Docket # 113179-3 and a proximal o-ring 159 is secured to the outer sheath hub 152 and extends radially from adjacent the proximal sheath hub end 154 and into abutting relationship with the inner surface of the hub chamber 32 proximally adjacent the activator port 139. Thus, as best shown in Figures 3 and 16, the distal and proximal o-rings 158, 159 establish a sealed chamber 160 that is disposed radially adjacent and in fluid communication with the activator port 139, extending between the inner surface of the hub chamber 32 and the outer sheath hub 152 and bounded on its ends by the distal and proximal o-rings 158, 159

[0062] As best illustrated in Figure 17, after the base material 22 is deployed at the wound site, the activator 127 is delivered from the activator syringe 138, sequentially through the activator line 140 and the activator port 139, and into the sealed chamber 160. The pressure of the activator 127, as established by the syringe injection, then builds up in the sealed chamber 160 and causes the outer sheath hub 152 to translate relative to the central lumen 20 and the delivery hub 24 in the proximal direction. As mentioned previously, the distal sheath hub end 156 is connected to the outer sheath 128 and thus, as best shown in Figures 18 and 19B, this proximal retraction of the outer sheath hub 152 also effectuates a retraction or proximal sliding movement of the outer sheath 128 relative to the delivery catheter 14 which ultimately opens the annulus 130 adjacent the distal outer sheath end 132. For example, as shown in Figure 18, in accordance with a first embodiment, the outer sheath hub 152 is proximally retracted by the pressure within the sealed chamber 160 until the distal outer sheath end 132 no longer covers and is disposed in proximally spaced relationship with (i.e., is no longer line fit with) the annular flange 150, and thus the distal portion of the annulus 130 is directly openAtorney Docket # 113179-3 to an environment of the delivery catheter 14. However, as shown in Figure 19B, in accordance with a second embodiment, the annular flange 150 defines a plurality of axially extending flow channels 162 which commence in axially spaced relationship from the distal catheter end 18 but extend proximally through the remaining portion of the annular flange 150 and into fluid communication with the annulus 130. Thus, in this embodiment, the outer sheath hub 152 is proximally retracted until a distal portion of the axially extending flow channels 162 are no longer covered by the outer sheath hub 152 and thus the annulus 130 is indirectly disposed in fluid communication with the environment of the delivery catheter 14 by way of the now-open axially extending flow channels 162.

[0063] In either embodiment, the opening of the annulus 130 at the distal outer sheath end 132 advantageously occurs automatically for the user, simply by applying a pressure to the activator syringe 138 and building up pressure in the sealed chamber 160. Put another way, the outer sheath 128 is automatically unsheathed from the annular flange 150 to unseal the annulus 130 at the distal outer sheath end 132. However in each embodiment, the initial automatic retraction of the outer sheath hub 152 does not immediately establish fluid communication of the activator 127 with the annulus 130. Rather, as best shown in Figure 16, during this initial retraction of the outer sheath hub 152 the proximal o-ring 159 is still disposed in radially abutting and sealed relationship with the inner surface of the hub chamber 32 to prevent the activator 127 from reaching the annulus 130. This also builds-up additional pressure within the sealed chamber 160 to effectuate additional proximal translation of the outer sheath hub 152. As best shown in Figures 3 and 16-17, the hub chamber 32 includes an increased innerAtorney Docket # 113179-3 diameter portion 164 disposed adjacent the proximal hub end 30 and which has an increased inner diameter being greater than an outer proximal o-ring diameter of the proximal o-ring 159. Thus, the outer sheath hub 152 continues to translate proximally until the proximal sheath hub end 154 (and the proximal o-ring 159) is disposed within the increased inner diameter portion 164 of the hub chamber 32, at which point the activator 127 is allowed to flow around the proximal o-ring 150, sequentially through the increased inner diameter portion 164 and the hub passageway 157, and into the annulus 130 to flow distally towards the distal outer sheath end 132 and into deployment at the wound site. This position of the proximal o-ring 159 within the increased inner diameter portion 164 also releases the built-up pressure within the sealed chamber 160 (since it is no longer sealed, and rather open proximally to the increased inner diameter portion 164 of the hub chamber 32). Thus, the proximal translation of the outer sheath hub 152 also ceases once the proximal o-ring 159 is disposed within the increased inner diameter portion 164 of the hub chamber 32.

[0064] Obviously, many modifications and variations of the present disclosure are possible in light of the above teachings and may be practiced otherwise than as specifically described.

Claims

Atorney Docket # 113179-3CLAIMSWhat is claimed is:

1. A hemostasis delivery apparatus for delivering a base material to a wound site of a patient, the hemostasis delivery apparatus comprising:a catheter assembly having a delivery catheter which extends along an axis A from a proximal delivery catheter end to a distal delivery catheter end;said delivery catheter defining a central lumen extending between said proximal and distal delivery catheter ends;a screw syringe assembly having a barrel extending from a proximal barrel end to a distal barrel end for being disposed in fluid communication with said central lumen adjacent said distal delivery catheter end;said barrel defining a barrel cavity which houses a predetermined amount of the base material;said screw syringe assembly including a plunger extending within said barrel and axially advanceable along the axis and towards said distal barrel end to inject the predetermined amount of the base material into said central lumen of said delivery catheter; andsaid plunger rotatable about the axis to establish the axial advancement of said plunger within said barrel via a threaded mechanical advantage.

2. The hemostastis delivery apparatus as set forth in Claim 1, further comprising:said screw syringe assembly including a housing disposed adjacent said proximal barrel end and defining a through-passage extending along the axis;Atorney Docket # 113179-3 said plunger extending from a proximal plunger end disposed outside of the housing and into and along said through-passage to terminate at a distal plunger end disposed inside of said barrel cavity;said plunger presenting a plurality of plunger threads extending between said proximal and distal plunger ends; anda split nut presenting a plurality of split nut threads, said split nut disposed within said housing and biased radially towards said through-passage to threadingly couple said plunger threads and said split nut threads and establish said threaded mechanical advantage.

3. The hemostasis delivery apparatus as set forth in Claim 2, wherein said screw syringe assembly includes a rotation knob attached to said proximal plunger end and being rotatable by a user to axially advance and drive said plunger towards said distal barrel end via said threaded mechanical advantage.

4. The hemostasis delivery apparatus as set forth in Claim 2, wherein said plurality of split nut threads having a hemispherical cross-section when viewed transverse to the axis, and said split nut biased radially towards said through-passage by a biasing member.

5. The hemostasis delivery apparatus as set forth in Claim 4, wherein said housing includes a quick draw button radially advanceable by a user into engagement with said split nut to overcome the bias of said biasing member and threadingly decoupleAtorney Docket # 113179-3 said plunger threads and said split nut threads for releasing said threaded mechanical advantage and allowing said plunger to be drawn proximally by a user.

6. The hemostasis delivery apparatus as set forth in Claim 1, further comprising:said catheter assembly including a delivery hub arranged on said delivery catheter adjacent said proximal delivery catheter end;said delivery hub including a hub body which extends along the axis from a distal hub end to a proximal hub end, the proximal hub end disposed proximal of and in spaced relationship with said proximal delivery catheter end;said delivery hub presenting a threaded bore disposed adjacent said proximal hub end; andsaid distal barrel end of said barrel presenting external threads being complementary shaped to said threaded bore for establishing a threadingly coupled relationship between said catheter assembly and said screw syringe assembly.

7. The hemostasis delivery apparatus as set forth in Claim 6, wherein said hub body defines a hub chamber disposed between said proximal and distal hub ends, said hub chamber being in communication with said threaded bore; said delivery catheter extending through said hub chamber to dispose said proximal delivery catheter end within said threaded bore in spaced relationship with said proximal hub end; and said distal barrel end including a tip disposed in fluid communication with said barrel cavity and whichAtorney Docket # 113179-3 is inserted into said central lumen at said proximal delivery catheter end when said distal barrel end is threadingly coupled to said threaded bore of said hub body.

8. A hemostasis delivery apparatus for delivering a base material to a wound site of a patient, the hemostasis delivery apparatus comprising:a catheter assembly having a delivery catheter which extends along an axis from a proximal delivery catheter end to a distal delivery catheter end for being disposed within a patient and adjacent the wound site;said delivery catheter defining a central lumen extending between said proximal and distal delivery catheter ends, said central lumen being pre-loaded with a predetermined amount of the base material;a pump assembly operably coupled to said catheter assembly and including a pump handle and a piston catheter, said piston catheter extending along the axis from a proximal piston catheter end connected to said pump handle to a distal piston catheter end disposed adjacent said proximal delivery catheter end in axial alignment with said delivery catheter;a piston component disposed within said piston catheter and in a pre-loaded condition extending along the axis from a proximal piston component end disposed adjacent the proximal piston catheter end to a distal piston component end disposed adjacent the distal piston catheter end; anda pump actuator translatably disposed within said pump housing and axially advanceable distally relative to said pump housing from a retracted position to an axially advanced position to axially drive said pre-loaded piston component along the axis andAtorney Docket # 113179-3 distally within and relative to said piston catheter for axially advancing the distal piston component end into said central lumen to advance the pre-loaded base material through the central lumen and out of the distal catheter end to deliver the base material to the wound site.

9. The hemostasis delivery apparatus as set forth in Claim 8, further comprising:said pump handle including an actuator portion extending along the axis, a handle portion extending radially away from said actuator portion, and a pump chamber aligned on the axis and disposed at an intersection of said actuator and handle portions;said handle portion including a pump reservoir disposed in fluid communication with said pump chamber and filled with a predetermined amount of liquid;said pump actuator translatably disposed within said actuator portion of said pump housing and in a static condition extending from a distal actuator end disposed adjacent said pump chamber to a proximal actuator end disposed outside of and proximally to said actuator portion;wherein said pump actuator is retractable proximally relative to said actuator housing from the static condition to the retracted position to draw the predetermined amount of liquid from the pump reservoir and into said pump chamber; andwherein subsequent axially advancement of said pump actuator from the retracted position to the axially advanced position pushes the liquid out of said pump chamber and into said piston catheter in engaging relationship with said proximal piston component end to exert a hydraulic pressure on said proximal piston component end andAtorney Docket # 113179-3 establish said axial driving movement of said piston component distally within and relative to said piston catheter.

10. The hemostasis delivery apparatus as set forth in Claim 9, wherein said proximal retraction of said pump actuator from the static condition to the retracted condition additionally draws the liquid into an actuator chamber disposed within said actuator portion and established by a space vacated by the retracted pump actuator, said actuator chamber being disposed in fluid communication with said pump chamber; and wherein subsequent axially advancement of said pump actuator from the retracted position to the axially advanced position sequentially pushes the liquid out of the actuator chamber, into the pump chamber, and then into said delivery catheter.

11. The hemostasis delivery apparatus as set forth in Claim 10, further comprising a one-way fluid valve disposed between said pump reservoir and said pump chamber, and a two-way fluid valve disposed between said pump chamber and said actuator chamber.

12. The hemostasis delivery apparatus as set forth in Claim 8, wherein said piston component includes an inner core that extends between said distal and proximal component ends and is housed within an outer polymer jacket.

13. The hemostasis delivery apparatus as set forth in Claim 8, further comprising:Atorney Docket # 113179-3 said catheter assembly including a delivery hub arranged on said delivery catheter adjacent said proximal delivery catheter end;said delivery hub including a hub body which extends along the axis from a distal hub end to a proximal hub end, said proximal hub end disposed proximal of and in spaced relationship with said proximal delivery catheter end;said delivery hub presenting a threaded bore disposed adjacent said proximal hub end; andsaid distal piston catheter end presenting a connector configured to threadingly engage with said threaded bore of said delivery hub to establish said operable coupling of said pump assembly and said catheter assembly.

14. The hemostasis delivery apparatus as set forth in Claim 13, further comprising:said catheter assembly including an outer sheath concentrically arranged around said delivery catheter to define an annulus extending radially between an inner surface of said outer sheath and an outer surface of said delivery catheter;said outer sheath extending from a distal outer sheath end disposed adjacent said distal catheter end to a proximal outer sheath end that terminates adjacent said hub chamber of said hub body in distally spaced relationship with said proximal catheter end;said hub body defining an activator port disposed in fluid communication with said hub chamber; andAtorney Docket # 113179-3 an activator line extending from a proximal line end operably connected to an activator source to a distal line end operably connected to said activator port for delivering an activator into the hub chamber, through the annulus and out of the distal outer sheath end after the base material has been delivered to the wound site.

15. The hemostasis delivery apparatus as set forth in Claim 14, further comprising:an elastomeric cap disposed in overlaying and sealed relationship between said distal outer sheath end and said outer surface of said delivery catheter to initially seal a distal portion of said annulus from an environment of said delivery catheter;said proximal outer sheath end of said outer sheath disposed in fluid communication with said hub chamber; andwherein said activator passing through said annulus and to said distal outer sheath end generates a force to overcome a cracking pressure of said elastomeric cap to free said sealed relationship and allow said activator to pass out of said annulus now being open adjacent said distal outer sheath end.

16. The hemostasis delivery apparatus as set forth in Claim 14, further comprising:said delivery catheter including an annular flange disposed adjacent said distal catheter end and having a stepped-up diameter;said inner surface of said outer sheath having an inner outer sheath diameter being approximately equal to said stepped up diameter of said annular flangeAtorney Docket # 113179-3 to initially seal a distal portion of said annulus from an environment of said delivery catheter; andsaid outer sheath axially translatable relative to said delivery catheter in response to said activator being delivered to said hub chamber to slide said distal outer sheath end proximally away from said distal catheter end and open said annulus adjacent said distal end for allowing said activator to pass through said annulus and out of said opened distal outer sheath end.

17. The hemostasis delivery apparatus as set forth in Claim 16, wherein said axial translation of said outer sheath slides said distal outer sheath end into proximally spaced relationship with said annular flange such that said distal outer sheath no longer covers said annular flange to open said annulus adjacent said distal catheter end.

18. The hemostasis delivery apparatus as set forth in Claim 16, wherein said annular flange defines a plurality of axially extending flow channels which commence in axially spaced relationship with said distal catheter end but extend proximally through a remaining portion of said annular flange and into fluid communication with said annulus, and wherein said axial translation of said outer sheath slides said outer sheath proximally relative to said annular flange until a portion of said axially extending flow channels are no longer covered by said distal outer sheath end to open said annulus adjacent said distal catheter end.Atorney Docket # 113179-3 19. The hemostasis delivery apparatus as set forth in Claim 14, further comprising:an outer sheath hub slideably disposed within said hub chamber and extending from a proximal sheath hub end disposed proximal of and adjacent to said activator port to a distal sheath hub end connected to said proximal outer sheath end of said outer sheath;said outer sheath hub disposed in concentrically surrounding and axially translatable relationship with said outer surface of said delivery catheter between said proximal and distal sheath hub ends to define a hub passageway disposed in fluid communication with said annulus;a distal o-ring disposed within said hub chamber distally adjacent said activator port and extending radially between an inner surface of said hub chamber and said outer sheath hub; anda proximal o-ring secured to said outer sheath hub and extending radially from adjacent said proximal sheath hub end and into abutting relationship with said inner surface of said hub chamber; anda sealed chamber disposed radially adjacent and in fluid communication with said activator port and extending between said inner surface of said hub chamber and said outer sheath hub, said sealed chamber bounded on its ends by said distal and proximal o-rings;wherein when said activator is delivered to said sealed chamber from said activator port a pressure builds up in said sealed chamber to cause said outer sheath hub to translate relative to said delivery catheter and said delivery hub in the proximal directionAtorney Docket # 113179-3 and simultaneously effectuate said proximal retraction of said outer sheath disposed in connected relationship to said outer sheath hub end.

20. The hemostasis delivery apparatus as set forth in Claim 19, further comprising:said hub chamber including an increased inner diameter portion disposed adjacent said proximal hub end and having an increased inner diameter being greater than an outer proximal o-ring diameter of said proximal ring;wherein the built-up pressure in said sealed chamber proximally translates said outer sheath hub until said proximal o-ring on said proximal sheath hub end is disposed within said increased inner diameter portion of said hub chamber, after which said activator flows around said proximal o-ring, sequentially through said increased inner diameter portion and said hub passageway, and into said annulus to flow distally towards said distal outer sheath end.

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